Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Colon
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the colon or rectum Advanced or metastatic disease Must have received a fluoropyrimidine-based regimen and an irinotecan-based regimen, either alone or in combination, for advanced disease May have relapsed within 6 months of adjuvant therapy with fluorouracil (5-FU) (or combination 5-FU and irinotecan) and progressed after single-agent irinotecan Measurable disease No known brain metastases Performance status - ECOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No history of thrombotic or hemorrhagic disorders Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 5 times ULN INR no greater than 1.5 PTT no greater than ULN Creatinine no greater than 1.5 times ULN Proteinuria less than 1+ (i.e., 0 or trace) Protein less than 500 mg by 24-hour urine collection Proteinuria secondary to ureteral stents allowed No proteinuria secondary to nephropathy Controlled hypertension (less than 150/100 mm Hg) allowed if on a stable antihypertensive regimen No prior myocardial infarction No uncontrolled congestive heart failure No unstable angina within the past 3 months No serious nonhealing wound, ulcer, or bone fracture Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior bevacizumab See Disease Characteristics Recovered from prior chemotherapy No prior oxaliplatin At least 2 weeks since prior radiotherapy and recovered At least 28 days since prior major surgical procedure At least 10 days since prior aspirin dose of more than 325 mg/day No concurrent therapeutic anticoagulation except prophylactic anticoagulation of venous access device No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or cilostazol) No concurrent oral cryotherapy on day 1 of oxaliplatin administration
Sites / Locations
- Eastern Cooperative Oncology Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm I (bevacizumab, oxaliplatin, leucovorin, fluorouracil)
Arm II (oxaliplatin, leucovorin calcium, fluorouracil)
Arm III (bevacizumab)
Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive leucovorin calcium IV over 2 hours and fluorouracil (5-FU) IV over 22 hours on days 1 and 2.
Patients receive oxaliplatin, leucovorin calcium, and 5-FU as in arm I.
Patients receive bevacizumab as in arm I.