• Breast Cancer Studies
• Gastrointestinal Cancer Studies
• Genitourinary Cancer Studies (includes Prostate)
• Gynecological Cancer Studies
• Head and Neck Cancer Studies
• Leukemia Studies
• Lung Cancer Studies (Non-Small Cell)
• Lung Cancer Studies (Small Cell)
• Lymphoma Studies (Non-Hodgkin's)
• Lymphoma Studies (Hodgkin's)
• Melanoma Studies
• Myeloma Studies
• Miscellaneous Studies
• Sarcoma Studies BREAST CANCER STUDIES: Study: ECOG PACCT-1
"Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial" Purpose: This study is for women who have breast cancer that is estrogen receptor and/or progesterone receptor positive and that has not spread to the lymph nodes. Although surgery for this type of cancer is done, there is a chance that the cancer may reoccur in the breast, chest wall, or other parts of the body. Chemotherapy is usually recommended if the risk of recurrence is at least 10% despite hormonal therapy. Approximately 80 - 85% of patients with this stage of disease would be cured with hormonal therapy alone. This study involves the use of a new diagnostic test called the Oncotype DX. This test will be used to study a section of the cancer tissue taken during surgery. The test uses several small slices of the tumor section. These sections will be analyzed in a specialized laboratory that can measure the levels of a specific group of genes in the tumor. The results of the test are computed into a score (called the Recurrence Score). This Recurrence Score is the likelihood that the cancer will relapse or come back in 10 years. The purpose of this study is to determine whether subjects who have a tumor with an Oncotype DX Recurrence Score of 11 - 25 benefit from chemotherapy. Also, the study will confirm that most subjects who have Oncotype DX Recurrence Score of less than 10 may be cured with hormonal therapy alone. Additionally, the study will collect follow-up information regarding the health status of all women who participate in the study. This will allow researchers to evaluate new diagnostic tests in the future that may predict benefit or side effects from certain treatments. Study: IBCSG 24-02
“A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer” Purpose: This study is being done to see if shutting down the ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just giving tamoxifen alone in premenopausal women. It will also test whether a hormone drug called exemestane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries. In addition, the side effects of these different study treatments will be evaluated. Study: Novartis CZOL446E2352
"A Prospective, Randomized, Double-blind, Stratified, Placebo-controlled, Multi-center, 3-arm Trial of the Continued Efficacy and Safety of Zometa (Every 4 Weeks vs. Every 12 Weeks vs. Placebo) in Patients with Documented Bone Metastases from Breast Cancer" Purpose: The FDA approval in the United States for patients with bone metastases is for Zometa to be used for 1 year. This study will compare the efficacy of Zometa in dosing schedules beyond one year of every month vs. every 3 months vs. placebo. The reason for this study is to find out whether Zometa continues to decrease skeletal-related events (like breaking bones) after a year and if it does continue to prevent them, and which dose is better (once a month or every 3 months). Another important reason for the study is to look at how safe Zometa is after 1 year. Study: NSABP B-36
"A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC), in Patients with Node-Negative Breast Cancer"
Purpose: This study is being done to find out if 6 treatments of one combination of chemotherapy drugs (f-fluorouracil [5-FU], epirubicin and cyclophosphamide) is better at treating breast cancer than four treatments of a standard combination of chemotherapy drugs (doxorubicin [adriamycin] and cyclophosphamide). 5-FU, epirubicin, and cyclophosphamide are one of several combinations used for women with positive nodes but the combination has not been evaluated in women with negative nodes. Study: NSABP B-39
"Radiation Therapy in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer" Purpose: Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. The purpose of this study is to see if partial breast irradiation (PBI) is as good as or better than whole breast irradiation (WBI) in keeping cancer from coming back in the breast. WBI is a standard treatment after a lumpectomy. WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. PBI is radiation therapy given only to the area of the breast where the cancer was removed. PBI is given 2 times a day on 5 days. PBI may be given over a period of 5 to 10 days. Study: NSABP B-41
"A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer" Purpose: This study is being done to test lapatinib, when given with standard breast cancer treatments. Lapatinib is a new therapy for HER2-positive breast cancer. One way to treat breast cancer is by using chemotherapy drugs. Chemotherapy drugs work by directly killing cancer cells. Another way to treat breast cancer is by using “targeted therapies.” Targeted therapies work by blocking or interfering with a specific part of the cancer cell to slow down or stop the tumor from growing. In this study, all patients will receive the standard chemotherapy drugs doxorubicin and cyclophosphamide (also called AC) followed by paclitaxel (also called Taxol®) before their breast surgery. All patients will also receive a targeted therapy called trastuzumab (also called Herceptin®). Trastuzumab targets a protein called the HER2 protein on the surface of the cancer cell to block the growth signal. The combination of AC followed by paclitaxel and trastuzumab is now a standard way of treating HER2-positive breast cancer. In addition to the standard treatments, some patients in this study will receive a new drug called lapatinib (also called Tykerb®) before their breast surgery. Lapatinib is a targeted therapy like trastuzumab, but lapatinib works inside the cancer cell to block the HER2 protein. Study: NSABP B-42
"Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer" Purpose: This study will look at the effects (good and bad) that letrozole has on postmenopausal women with receptor-positive breast cancer. The main purpose of the study is to learn whether or not continuing hormonal therapy with an AI called letrozole for 5 additional years after already taking 5 years of hormonal therapy (which included an AI) can further reduce the chance of breast cancer returning. Letrozole is investigational (still being researched) for use in subjects who have already received an AI as part of their 5 years of hormonal therapy. Letrozole is considered “investigational” because it has not yet received approval from the U.S. Food and Drug Administration (FDA) or the Canadian Health Products and Food Branch (HPFB) for use after 5 years of hormonal therapy which included an AI. Another reason for doing this study is to find out whether or not taking the study drug letrozole after taking 5 years of hormonal therapy that included letrozole (or other AI) causes more thinning of bones (osteoporosis) which can cause bones to break more easily. We also want to find out if letrozole increases the chance of heart attack, stroke, and other problems with blood vessels called arteries. Study: SWOG S0221
“Phase III Trial of Continuous Schedule AC + G Vs. Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer” Purpose: The main purpose of this study is to compare the effects (good and bad) of four different treatments (or “regimens”) for breast cancer. All of these treatments include essentially the same drugs given in different ways and on different schedules. All of the treatments use standard, commercially available medicines that are known to be effective for treating breast cancer. The chance that this cancer will return or spread depends on a number of factors. A discussion should take place with the health care provider and/or the study doctor regarding the chances for return or spread in each particular case both with and without various treatments. Study: SWOG S0226
"Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women with Metastatic Breast Cancer"
Purpose: The purpose of this study is to find out what effects (good or bad) the combination of the hormonal agents anastrozole and fulvestrant have over anastrozole alone on patients and their breast cancer. Both drugs anastrozole and fulvestrant are approved for the treatment of metastatic breast cancer. However, the combination of the two drugs is considered experimental. Study: SWOG S0307
"Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer" Purpose: This study is investigational and is being done to find out if adding a drug (a bisphosphonate) to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body. The use of these drugs in this study is investigational, which means they have not been approved for this use by the U.S. Food and Drug Administration (FDA). "Bisphosphonates" are a group of drugs that have strong effects on the bones and have been shown to strengthen the bones in many patients who take them. Study: SWOG S0430
"Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients with Metastatic Breast Cancer" Purpose: This study is being done to find out if taking two drugs by mouth, cyclophosphamide plus capecitabine, will help shrink this type of breast cancer and keep the cancer from becoming worse. The use of these drugs in combination in this study is investigational, which means they have not been approved for this use by the U.S. Food and Drug Administration (FDA). Study: SWOG S0500
"Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy"
Purpose: The purpose of this experimental study is to find out if the CellSearch™ blood test, which identifies tumor cells in the blood, can predict survival outcome in subjects with metastatic breast cancer. These tumor cells are called circulating tumor cells (CTCs). The CellSearch™ blood test may allow doctors to tell if current chemotherapy treatments are not working before signs develop that the cancer is getting worse. This is based upon a prior study that showed that most women with high numbers of CTCs had worsening of their breast cancer within 1 to 3 months. In this prior study, increase in the size of a tumor or spread of cancer in the body was determined by standard clinical tests such as physical examinations, x-rays and scans, and not by the CellSearch™ blood test. This study will test whether switching to another form of treatment based upon the results of the CellSearch™ blood test helps people live longer. In addition, this study will be used to further confirm results of the prior study, which showed that subjects with less than 5 CTCs before they begin treatment live longer than those with greater than or equal to 5 CTCs. This study is not testing specific treatments, but rather the way decisions to change current treatments are made. The study will also look at whether women who have elevated CTCs after 3 weeks of chemotherapy have a longer overall survival rate staying on their present treatment, or changing chemotherapy. And the study will examine how CTC counts change with different chemotherapies. Study: SWOG S0622
"Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone"
Purpose: Dasatinib is a drug that may be able to slow the growth of breast cancer, and it may be able to prevent breast cancer from spreading to and breaking down bones. This study is investigational and is being done to find out if taking the investigational drug dasatinib by mouth by either of two different dosing schedules will help control this type of cancer and whether it will affect bones. An investigational drug is one that is not approved by the U.S. Food and Drug Administration (FDA).
GASTROINTESTINAL CANCER STUDIES: Study: CALGB C80101 (Gastric or Gastroesophageal)
“Phase III Intergroup Trial of Adjuvant Chemoradiation after Resection of Gastric or Gastroesophageal Adenocarcinoma” Purpose: The Cancer and Leukemia Group B (CALGB), in cooperation with other cancer researchers, is trying to develop better treatments for stomach cancer which would result in fewer subjects having their cancer come back. One approach being studied is the use of newer chemotherapy combinations. A recent study found that subjects who received the drugs 5-fluorouracil (5-FU) and leucovorin in combination with radiation therapy, after surgical removal of a stomach cancer, had a lower risk of the cancer coming back. This is the drug combination that is most commonly used for people with this type of cancer. However, the drug combination of epirubicin, cisplatin and 5-FU followed by the continuous intravenous infusion of 5-FU chemotherapy with radiation therapy has been offered as a new approach for subjects after a surgical removal of stomach cancer, and is experimental. Currently, it is not known which of these two treatments is more effective. Study: CALGB 80405 (Colon or Rectal)
"A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU / Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum" Purpose: This study is being done to evaluate the effects (good and bad) of different regimens of chemotherapy. There are two common combinations of chemotherapy drugs used to treat this type of cancer. One uses 5-fluorouracil (also called 5-FU), leucovorin, and oxaliplatin, and is also called "FOLFOX;" the other combination uses 5-FU, leucovorin, and irinotecan, this combination is also called "FOLFIRI." At the present time, the U.S. Food and Drug Administration (FDA) has approved each of these treatments for colon or rectal cancer. The FDA has also approved the use of a drug called bevacizumab in combination with these chemotherapy regimens. Bevacizumab plus either of these chemotherapy regimens is considered the standard of care for most patients. Cetuximab is an antibody that targets and blocks a specific part of the cancer tumor that is felt to encourage tumor growth, called the EGFR receptor (a protein on the surface of cancer cells that can be activated to stimulate the cell to grow and multiply). About 70% of all colon and rectum tumors have this receptor. Cetuximab is approved by the FDA for the treatment of colorectal cancer in patients who have developed progressive cancer following the use of irinotecan. The purpose of this study is to determine whether one of the 2 combinations (cetuximab plus chemotherapy or cetuximab plus bevacizumab plus chemotherapy) is better than the combination of bevacizumab with chemotherapy. Study: ECOG 2204 (Pancreas)
"An Intergroup Randomized Phase II Study of Bevacizumab or Cetuximab in Combination with Gemcitabine and in Combination with Chemoradiation (Capecitabine and Radiation) in Patients with Completely-Resected Pancreatic Carcinoma" Purpose: The purpose of this study is to test the safety and side effects of two new drugs, bevacizumab or cetuximab, in combination with gemcitabine and in combination with chemoradiation (capecitabine and radiation) for patients with resected (surgically removed) pancreas cancer. In addition this study will test the safety of using capecitabine, a pill form of chemotherapy, with radiation for subjects with resected pancreas cancer. Study: ECOG E5202 (Colon)
"Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer" Purpose: To see if specific biological features (often called tumor markers or markers) found in the colon tumor cells can be used to predict if tumors come back in patients with stage II colon cancer. To compare the effects (good and bad) of a combination of chemotherapy drugs, when given with and without the study drug, bevacizumab, on patients with stage II colon cancer at high-risk for recurrence (return of cancer). To see if adding bevacizumab to the other cancer-fighting agents is better for treating colon cancer patients, who may be at increased risk for recurrence based on the markers shown in their tumor. To see if adding bevacizumab will help prevent the cancer from coming back. The other chemotherapy drugs given in this study are 5-fluorouracil (5-FU), leucovorin and oxaliplatin. Study: ECOG 5204 (Rectal)
"Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation" Purpose: The purpose of this study is to compare the effects (good and bad) of a combination of chemotherapy drugs, when given with or without another drug called bevacizumab. The study will include subjects with stage II or stage III rectal cancer who have had pre-operative chemoradiation. There have been very few studies of different combinations of chemotherapies for subjects with rectal cancer who have already had surgery and radiation. This study will compare the overall survival in subjects with clinical stage II and stage III rectal cancer who received pre-operative chemoradiation and surgery and will compare the investigational use of a combination of oxaliplatin, fluorouracil, and leucovorin with or without bevacizumab. The study will also assess if adding bevacizumab to these chemotherapy drugs will be better at treating rectal cancer and if it will help prevent the cancer from coming back. Study: NCCTG N0147 (Colon)
"A Randomized Phase III Trial of Irinotecan (CPT-11) and / or Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU) / Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer" Purpose: The study is being done in subjects who have had surgery for colon cancer. It is being done to compare the safety and effectiveness of six different groups of drugs in preventing the return of colon cancer. These drug combinations, namely cetuximab (C225), irinotecan (CPT-11), and oxalipalatin (OXAL), are considered experimental (investigational) in the stage of colon cancer being studied. The study is also being done to compare the effects of the treatments on quality of life and the side effects in the different groups. The study is also trying to determine if C225 helps prevent cancer from coming back when added to chemotherapy. Study: NSABP R-04 (Rectal)
"A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with Preoperative Radiation Therapy and Continous Intravenous Infusion (CVI) of 5-Fluorouracil (5-FU) in the Treatment of Patients with Operable Carcinoma of the Rectum" Purpose: This study is being done to see if taking a drug called capecitabine as a pill, twice a day by mouth during the weeks subjects receive radiation therapy, is as good as the standard treatment with the drug 5-fluorouracil (5-FU) given by continuous intravenous infusion (CVI) during the weeks patients receive radiation therapy. The study will also look at these two different treatment options and obtain important information regarding quality of life for both. Study: SWOG S0356 (Esophageal)
"Oxaliplatin Plus Protracted Infusion 5-Fluorouracil (5-FU) and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates" Purpose: The purpose of this study is to find out what effects (good and bad) being treated with oxalipalatin and 5-FU plus radiation therapy before surgery has on patients and their esophageal cancer. This research is being done to find a more effective treatment for this type of cancer. The study will look at whether treatment with oxalipalatin, 5-FU, and radiation before surgery will increase the chance that the surgeon can remove all of the cancer during surgery. It will also look at whether treatment with oxalipalatin and 5-FU after surgery will be of benefit to patients with esophageal cancer. GENITOURINARY CANCER STUDIES Study: CALGB 90401 (Prostate)
"A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Docetaxel and Prednisone with and without Bevacizumab in Men with Hormone Refractory Prostate Cancer" Purpose: The purpose of this study is to compare the effects (good and bad) of the combination of the chemotherapy drug docetaxel and prednisone (steroid), with the combination of docetaxel, prednisone, and the experimental drug bevacizumab on men with hormone refractory prostate cancer to find out which is better. Bevacizumab is an antibody that is thought to inhibit the growth of new blood vessels. Bevacizumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of colorectal cancer, but it is investigational for the treatment of prostate cancer, and has not been approved by the FDA for this use. This research is being done to see if adding bevacizumab to the standard treatment of docetaxel and prednisone will delay the growth of the cancer and help men live longer with this type of cancer. Study: ECOG E2805 (Kidney)
"A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma" Purpose: This research is being done because there is no effective therapy to prevent recurrence of kidney cancer. The study will also determine if either Sunitinib or Sorafenib can prevent recurrence of this type of kidney cancer and will compare the effects (both good and bad) of Sunitinib and the Sorafenib with Placebo (pills that look like the study drugs, but are inactive or do not contain the drug) on people with kidney cancer to see which is better. It is not known whether the benefits of taking either Sunitinib or Sorafenib will outweigh the risks. Both Sorafenib and Sunitinib have been approved by the U.S. Food and Drug Administration (FDA) for use in advanced kidney cancer. Study: ECOG E3805 (Prostate)
"Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer" Purpose: The purpose of this study is to determine whether giving docetaxel chemotherapy, at the time hormonal therapy is started and when the hormonal therapy is no longer working, is more effective than giving it only at the time the hormonal therapy is no longer working. Hormonal therapy refers to drugs or surgical procedures such as an orchiectomy used to lower testosterone. This puts prostate cancer into remission in most patients as the testosterone is like a fuel for the cancer. It is the standard to give this as the only treatment for your cancer. Normally chemotherapy is reserved for when a patient’s cancer starts to grow again despite having a low testosterone level. In this study participants will either get docetaxel when starting hormonal therapy or when/if their cancer grows with a low testosterone level. If chemotherapy is given when hormones are started for the first time, chemotherapy may be given when/if the cancer grows back with a low testosterone level. Docetaxel is approved when it is given after the cancer grows back, but it is investigational when it is given at the start of hormonal therapy. An investigational drug is one that is not approved by the U.S. Food and Drug Administration (FDA). If the disease worsens while participants are on hormone treatments, the study doctor will consider the next treatment carefully. This study plan has asked but not required that the study doctor use docetaxel (a type of chemotherapy) once the disease worsens, even if the participant has received docetaxel when starting hormone therapy. The study doctor may also try another hormone treatment before starting docetaxel chemotherapy. The purpose of this study is to determine whether receiving docetaxel both when hormone therapy starts (or within 90 days of beginning hormonal therapy) as well as when the disease worsens, is better than only receiving docetaxel when the disease gets worse. This study will let us know which approach is more effective in treating prostate cancer. Study: GPC Biotech SAT3-06-04 (Prostate)
"Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)" Purpose: When prostate cancer no longer responds to hormone therapy, it is called Hormone Refractory Prostate Cancer (HRPC). For this stage of disease, there is no approved treatment. All treatments for this stage of HRPC are considered experimental (investigational). The study will be testing to see if an experimental drug called satraplatin, taken with prednisone (which is not an experimental drug), is safe and helpful in the treatment of HRPC.
GYNECOLOGIC/OVARIAN CANCER STUDIES
Study: GOG 0209 (Endometrial)
"Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer" Purpose: This study is being done on women, who have cancer of the endometrium (lining of the womb) that cannot be cured with surgery or radiation therapy. In a previous study, women with an advanced stage of endometrium cancer showed improved chances of survival after receiving chemotherapy. In advanced or recurrent endometrial cancer, the Gynecologic Oncology Group (GOG) has used chemotherapy with the drugs cisplatin, doxorubicin and paclitaxel to treat these patients. Additionally, other doctors have used the drugs carboplatin and paclitaxel to treat similar patients. Both of these treatments have been shown to shrink tumors in patients with endometrial cancer. The purpose of this study is to find out whether treatment with the two-drug combination of carboplatin and paclitaxel is as good as the current standard three-drug combination of cisplatin, doxorubicin, and paclitaxel. Side effect information will also be analyzed to see if there are any differences between the two-drug and three-drug chemotherapy combinations with regard to ease of treatment and patient tolerance. Lastly, there are no known treatments for endometrial cancer that have been shown to be better than these two chemotherapy regimens. Study: GOG 0218 (Ovarian)
"A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer" Purpose: The purpose of this study is to compare the effects (good and bad) of the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel alone in women with ovarian or peritoneal primary cancer. Effectiveness of treatment will be measured in terms of survival, time without evidence of cancer growth, and quality of life (wellness and physical functioning). Study: GOG 0219 (Cervical)
"Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer" Purpose: To determine if combining tirapazamine (TPZ) with cisplatin during radiation therapy increases progression-free survival (PFS) compared with cisplatin and radiation therapy. Tirapazamine is an investigational study drug. An investigational drug is one that is not approved by the U.S. Food and Drug Administration (FDA). Head and Neck Cancer Studies Study: RTOG 0522
"A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab {Followed by Surgery for Selected Patients} for Stage III and IV Head and Neck Carcinomas" Purpose: The purpose of this study is to compare the effects (good and bad) of radiation therapy and chemotherapy (cisplatin) with radiation therapy, chemotherapy, and cetuximab on patients with this type of advanced head and neck cancer to find out which is better. Cetuximab has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with colorectal cancer, and when this study began, cetuximab was an experimental treatment for patients with head and neck cancer. In 2006, the FDA approved cetuximab for the treatment of head and neck cancer. Cetuximab may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. LEUKEMIA CANCER STUDIES
Study: SWOG S0106 (Acute Myeloid Leukemia)
“A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction with Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy with Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 56 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)”
Purpose: The main purpose of this study is to find out what effects (good and bad) this treatment has on patients with AML. It will also try to find out if subjects have more time before their leukemia comes back if they get an investigational drug, gemtuzumab ozogamicin (Mylotarg®), along with the usual chemotherapy treatment for acute myeloid leukemia. It will also look at whether or not adding the gemtuzumab ozogamicin (Mylotarg®) to the first chemotherapy treatment will allow more subjects’ conditions to go into remission (no active leukemia). And lastly, the study will find out if subjects who get gemtuzumab ozogamicin (Mylotarg®) along with chemotherapy have more frequent and/or serious side effects. Study: SWOG S0530 (Acute Lymphoblastic Leukemia)
"Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia" Purpose: The purpose of this study is to test the effects, good and/or bad, of a new combination of drugs (clofarabine and cytarabine) on acute lymphoblastic leukemia that has come back after initial treatment or not responded to previous treatment. Clofarabine has been approved by the Food and Drug Administration for treatment of relapsed/refractory ALL in children; however it has not been approved for the treatment of relapsed/refractory ALL in adults and is investigational for this use. Cytarabine is approved for the treatment of ALL.
LUNG CANCER (NON-SMALL CELL) STUDIES
Study: ECOG E1505
"Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery" Purpose: This research is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have the lung cancer recur (come back).
The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery for the removal of the lung cancer. We will compare the effects (good and bad) of adding bevacizumab to chemotherapy with standard chemotherapy alone on you and your lung cancer to see which is better at preventing the cancer from coming back. Study: Genentech AVF3752g
"A Study of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Brain Metastases Due to Non-Squamous NSCLC (PASSPORT)" Purpose: The purpose of this study is to determine the safety of bevacizumab with other medications to treat patients whose non-small cell lung cancer (NSCLC) has spread to the brain. This research study may also help us learn whether the combination of bevacizumab with chemotherapy or with erlotinib therapy extends life in the treatment of patients with lung cancer, and will also help to gather information about the side effects of bevacizumab with chemotherapy or with erlotinib therapy in patients with NSCLC that has spread to the brain. Study: SWOG S0424
"Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men" Purpose: It is known that smoking causes lung cancer; however, only 1 in 10 people who smoke get the disease. There are also people with lung cancer who have never smoked cigarettes in their life. The purpose of this study is to determine why women are more likely to be diagnosed with certain types of lung cancer than men are, and to see if factors other than smoking may put women at higher risk of lung cancer than men. The study also will assess what factors are associated with lung cancer in men and women who do not smoke. LUNG CANCER (SMALL CELL) STUDIES:
-- No Studies at this time. Please check again.
LYMPHOMA (NON-HODGKIN’S) STUDIES:
Study: CALGB 50303
"Phase III Randomized Study of R-CHOP vs. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas" Purpose: The purpose of this study is to compare the effects (good and bad) of two treatments (called R-CHOP with Dose-Adjusted EPOCH-R {DA-EPOCH-R, for short}) on people with this type of lymphoma to find out which is better. Currently, R-CHOP is considered standard of care (that is, a treatment that is widely used by most physicians) for this type of lymphoma, while DA-EPOCH-R is an investigational treatment developed over the last 14 years. The drugs involved in this research have all been approved by the FDA. The drugs being used in the DA-EPOCH-R combination have been approved for other cancers, but not in this combination for this type of lymphoma. For this reason, this particular drug combination is investigational.
Another important goal of the study is to analyze the tumors using scientific laboratories to better understand this type of lymphoma. This will help researchers to determine if one of these treatments is more effective in certain types of lymphomas. Study: SWOG S0016
“A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine 131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin’s Lymphomas” (Arm 1, CHOP only, of this study was permanently closed, effective 12/15/02) Purpose: The purpose of this study is to find out if a combination of drugs (called CHOP) followed by an antibody (rituximab) or a radioactive antibody (Iodine-131 anti-B-1 antibody – also called tositumomab) is able to stop the growth of this cancer. Another purpose of this study is also to find out if these treatments are safe and if the side effects of these treatments are tolerable. This study is also being conducted to see if patients treated with CHOP chemotherapy followed by the rituximab antibody or by tositumomab may have longer lasting tumor shrinkage, and hopefully cures. Study: SWOG S0313
"Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin's Lymphoma, Phase II"
Purpose: The purpose of this study is to find out what effects (good and bad) a commonly used drug combination called "CHOP" (cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by radiation treatment (RT) followed by a radioactive monoclonal antibody called "Yttrium-90 (Y-90) ibritumomab tiuxetan" (also called Zevalin®) will have on this type of cancer. This research is also being done to see if the CHOP regimen plus radiation plus Y-90 ibritumomab tiuxetan will help reduce or eliminate the cancer cells in subjects with non-Hodgkin's lymphoma. Study: SWOG S0515
"Combination Chemotherapy, Rituximab, and Bevacizumab in Treating Older Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma" Purpose: We are doing this experimental study to see if subjects treated with a combination of drugs (called “CHOP”) and rituximab plus bevacizumab may have longer lasting tumor shrinkage, than subjects treated with CHOP chemotherapy and rituximab alone. We also want to find out what effects (good and bad) an antibody (a substance the body makes as part of an immune response) called bevacizumab has on you and your lymphoma. This antibody is an experimental (investigational) drug and works against a protein which helps to form new blood vessels in tumors. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration for this use. This antibody is also sometimes called rhuMAb VEGF. Study: SWOG S0601
"Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma" Purpose: We are doing this experimental study to see if subjects treated with R-CHOP chemotherapy treatment (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) plus bortezomib (also called Velcade®) may have longer lasting tumor shrinkage than subjects treated with R-CHOP chemotherapy alone. We also want to find out what effects (good and bad) the study drug bortezomib has on you and your lymphoma. This study drug works by interfering with the growth of cancer cells, which are then eventually destroyed by the body.
LYMPHOMA (HODGKIN’S DISEASE) STUDIES
-- No studies at this time, please check again.
MELANOMA CANCER STUDIES
Study: ECOG E2603
"A Double-blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel, and BAY 43-9006 versus Carboplatin, Paclitaxel, and Placebo in Patients with Unresectable Locally Advanced or Stage IV Melanoma"
Purpose: The purpose of this study is to compare the effects (good and bad) of carboplatin and paclitaxel when given with BAY 43-9006 or placebo on people with this type of melanoma cancer to find out which treatment is better. Placebo does not contain active medication and should not influence the effect of carboplatin and paclitaxel. BAY 43-9006 may influence the effect, good and/or bad, of carboplatin and paclitaxel. Determining what effect BAY 43-9006 might have is the purpose of this study. BAY 43-9006 is investigational and has not been approved by the U.S. Food and Drug Administration for use in this type of cancer. Carboplatin and paclitaxel are FDA approved for use in other types of cancer. They are also investigational for use in this type of cancer. MYELOMA STUDIES: Study: SWOG S0120
“A Prospective Observational Biologic Study of Asymptomatic Patients with Monoclonal Gammopathy and Plasma Proliferative Disorders” Purpose: This study does not involve treatment. It is an “observational” study only. Monoclonal gammopathy, or myeloma without symptoms is considered to be at a stage that does not require immediate treatment and will be monitored for the purpose of learning more about the disease. The researchers want to understand more about genetic changes in the tumor and about the response of the immune system to the tumor. Sarcoma Studies Study: J & J ET743-SAR-3002--for more information contact one of the Cancer Research Nurses at Providence: (907) 261-5016. "A Multicenter, Open-Label Single-Arm Study of YONDELIS® (trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment" Purpose: The purpose of this research study is to provide an experimental drug, trabectedin, to eligible, previously treated- people with soft tissue sarcoma. The safety of trabectedin will also be evaluated during this study. Trabectedin is investigational, which means that it is not approved for sale by the Food and Drug Administration (FDA), or by any other regulatory agencies but is being studied in several other illnesses in addition to soft tissue sarcoma. Miscellaneous Studies: Study: Alexion P06-001--for more information contact one of the Cancer Research Nurses at Providence: (907) 261-3109. "Examination of PNH, by Level Of CD59 on REd and white blood cells, in bone marrow failure syndromes (EXPLORE)" Purpose: The primary objective of this study is to help determine the percentage of subjects with Aplastic Anemia (AA), Myelodysplastic Syndromes (MDS), and other bone marrow failure syndromes who have the PNH cells in their blood. PNH is an uncommon and potentially fatal blood disease that occurs at almost any age (average age 35 years) and is found equally between men and women. The percentage of patients with AA, MDS, and other bone marrow failure syndromes who have PNH is unclear. However, the determination of this number could represent an opportunity to detect, diagnose, and potentially treat patients with unrecognized PNH disease within these populations. | 
