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Phase III Randomized Study of Oxaliplatin, Fluorouracil, and Leucovorin Calcium With or Without Bevacizumab Versus Bevacizumab Only in Patients With Previously Treated Advanced or Metastatic Colorectal Adenocarcinoma
Alternate Title Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
Special Category: CTSU trial Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Patient Characteristics: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
Expected Enrollment A total of 880 patients (293 per treatment arm) will be accrued for this study within 18 months. (Arm III closed to accual as of 03/11/2003). Outline This is a randomized study. Patients are stratified according to ECOG performance status (0 vs 1 or 2), and prior radiotherapy (yes vs no). Patients are randomized to 1 of 3 treatment arms.
Courses in all arms repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response may receive 2 additional courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. Published ResultsCatalano PJ, Mitchell EP, Giantonio BJ, et al.: Outcomes differences for African Americans and Caucasians treated with bevacizumab, FOLFOX4 or the combination in patients with metastatic colorectal cancer (MCRC): results from the Eastern Cooperative Oncology Group Study E3200. [Abstract] J Clin Oncol 25 (Suppl 18): A-4100, 2007. Giantonio BJ, Catalano PJ, Meropol NJ, et al.: Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol 25 (12): 1539-44, 2007.[PUBMED Abstract] Giantonio BJ, Catalano PJ, O'Dwyer PJ, et al.: Impact of bevacizumab dose reduction on clinical outcomes for patients treated on the Eastern Cooperative Oncology Group's study E3200. [Abstract] J Clin Oncol 24 (Suppl 18): A-3538, 2006. Giantonio BJ, Catalano PJ, Meropol NJ, et al.: High-dose bevacizumab improves survival when combined with FOLFOX4 in previously treated advanced colorectal cancer: results from the Eastern Cooperative Oncology Group (ECOG) study E3200. [Abstract] J Clin Oncol 23 (Suppl 16): A-2, 1s, 2005. Mitchell EP, Alberts SR, Schwartz MA, et al.: High-dose bevacizumab in combination with FOLFOX4 improves survival in patients with previously treated advanced colorectal cancer: results from the Eastern Cooperative Oncology Group (ECOG) study E3200. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-169a, 2005. Giantonio BJ, Chen HX, Catalano PJ, et al.: Bowel perforation and fistula formation in colorectal cancer patients treated on Eastern Cooperative Oncology Group (ECOG) studies E2200 and E3200. [Abstract] J Clin Oncol 22 (Suppl 14): A-3017, 199s, 2004. Benson AB, Catalano PJ, Meropol NJ, et al.: Bevacizumab (anti-VEGF) plus FOLFOX4 in previously treated advanced colorectal cancer (advCRC): an interim toxicity analysis of the Eastern Cooperative Oncology Group (ECOG) study E3200. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-975, 2003. Related PublicationsGiantonio BJ, Meropol NJ, Catalano PJ, et al.: Magnitude of progression-free survival (PFS) improvement and treatment (Tx) duration in metastatic colorectal cancer (mCRC) for bevacizumab (BV) in combination with oxaliplatin-containing regimens: an analysis of two phase III studies. [Abstract] J Clin Oncol 25 (Suppl 18): A-4073, 2007. Saif MW, Mehra R: Incidence and management of bevacizumab-related toxicities in colorectal cancer. Expert Opin Drug Saf 5 (4): 553-66, 2006.[PUBMED Abstract] Gray R, Giantonio BJ, O'Dwyer PJ, et al.: The safety of adding angiogenesis inhibition into treatment for colorectal, breast, and lung cancer: the Eastern Cooperative Oncology Group's (ECOG) experience with bevacizumab (anti-VEGF). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-825, 2003. Trial Lead Organizations Eastern Cooperative Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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