- 14T-MC-JVBA - Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab vs. Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Platinum-Based Therapy. Accrual limited to Abington Cancer Care Specialists.
Rationale: The investigational drug used in this study may stop the growth of tumor cells by blocking its supply of nutrients and oxygen. It can be combined with chemotherapy drugs, which work in different ways to stop the growth of tumor cells. It is not yet known whether the investigational agent used in this study when given in combination with chemotherapy is more effective than chemotherapy alone for the treatment of non-small cell lung cancer (NSCLC). Purpose: The purpose of this study is to determine whether this investigational drug can help lung cancer patients live longer when it is given with chemotherapy treatment (docetaxel or taxotere). The study will include only patients who have already been treated with chemotherapy but who have progressed, either while being treated, or after completion of treatment. The study will also include genetic testing, which will help researchers to better understand which patients might benefit from this investigational drug in the future. (NCT01168973)
- 14T-MC-JVBB - A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients with Metastatic, Colorectal Carcinoma Progressive or Following First-Line Combination Therapy with Bevacizumab, Oxaliplatin, and a Fluoropyrimidine. Accrual limited to Abington Cancer Care Specialists.
Rationale: The investigational drug used in this study may stop the growth of tumor cells by blocking its supply of nutrients and oxygen. It can be combined with chemotherapy drugs, which work in different ways to stop the growth of tumor cells. It is not yet known whether the investigational agent used in this study when given in combination with chemotherapy is more effective than chemotherapy alone for the treatment of metastatic colorectal cancer. Purpose: The purpose of this study is to determine whether this investigational drug can help colorectal cancer patients live longer when it is given with chemotherapy treatment (FOLFIRI). The study will include only patients who have already been treated with chemotherapy but who have progressed, either while being treated, or after completion of treatment. The study will also include genetic testing which will help researchers to better understand which patients might benefit from this investigational drug in the future. (NCT01183780)
- ACOSOG - Z5041 - A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients with Operable Pancreatic Adenocarcinoma.
Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that need to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery. This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancer that can be removed by surgery. (NCT00733746)
- ACOSOG Z1031 - A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25mg daily), Letrozole (2.5 mg), or Anastrozole (1mg) in Postmenopausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer.
Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer. This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer. (NCT00265759)
- CALGB 40302 – Endocrine Therapy with or without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant with or without Lapatinib (GW572016) for Postmenopausal Women with Hormone Receptor Positive Advanced Breast Cancer.
Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer. This randomized phase III trial is studying fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive. (NCT 00390455)
- CALGB 40503 - Endocrine Therapy With or Without anti-VEGF Therapy: A Randomized, Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) For Women with Hormone Receptor-Positive Advanced Breast Cancer.
Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer. This randomized phase III trial is studying giving tamoxifen or letrozole together with bevacizumab to see how well it works compared with tamoxifen or letrozole alone in treating women with stage III or stage IV breast cancer. (NCT00601900)
- CALGB 70604 - A Randomized Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledornic Acid in Metastatic Cancer. (Breast Adenocarcinoma, Prostate Adenocarcinoma, Multiple Myeloma).
Zoledronic acid may stop the growth of cancer cells in bone and may help relieve some of the symptoms caused by bone metastases. It is not yet known which schedule of zoledronic acid is more effective in treating patients with metastatic cancer that has spread to the bone. This randomized phase III trial is studying two different schedules of zoledronic acid to compare how well they work in treating patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma with bone involvement. (NCT00869206)
- CALGB 90601 - A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab (IND #7921, NSC #704865) to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given together with or without bevacizumab in treating patients with urinary tract cancer. This randomized phase III trial is studying gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, cisplatin, and placebo in treating patients with advanced urinary tract cancer. (NCT00942331)
- CALGB 90802 - Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment With Tyrosine Kinase Inhibitors.
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus and bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. This randomized phase III trial is studying giving everolimus together with bevacizumab to see how well it works compared to everolimus alone in treating patients with advanced kidney cancer that progressed after first-line therapy. (NCT01198158)
- CALGB/SWOG – C80405 – A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225) for Patients with Untreated Metatastic Adenocarcinoma of the Colon or Rectum (Note: This new study title reflects removal of Arm C.)
Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer. This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer. (NCT00265850)
