1st Line Chemotherapy Alone or With Bevacizumab in Treating Older Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, stage IVA colon cancer, stage IVB colon cancer, adenocarcinoma of the rectum, stage IVA rectal cancer, stage IVB rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic colorectal adenocarcinoma
- Unresectable disease
- Measurable disease by RECIST criteria
- No cerebral metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Polynuclear neutrophils > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Proteinuria ≤ 1 g on 24-hour urine collection
- No unresolved intestinal occlusion or subocclusion
- No other progressive or unstabilized malignant tumor within the past 2 years
- No progressive gastroduodenal ulcer, wound, or bone fracture
No active cardiac disease including any of the following:
- Hypertension not adequately controlled
- Myocardial infarction within the past 6 months
- Poorly controlled angina
- Decompensated congestive cardiac insufficiency
No history of arterial thromboembolism or any of the following within the past 12 months:
- Cerebrovascular accident
- Transient ischemic attack
- Subarachnoid hemorrhage
- No history of distal or visceral ischemic arterial pathology ≥ grade 2 within the past 12 months
- No history of life-threatening pulmonary embolism within the past 6 months
- Must have completed the geriatric self-administered questionnaire and the geriatric "team" questionnaire (including the Spitzer QoL Index)
PRIOR CONCURRENT THERAPY:
No prior chemotherapy for metastatic disease
- More than 6 months since adjuvant chemotherapy after resection of the primary tumor
- More than 4 weeks since major surgery, excluding biopsy
- More than 4 weeks since radiotherapy
Sites / Locations
- Hôpital Avicenne
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Chemotherapy associated with bevacizumab
Chemotherapy
Chemotherapy (FOLFIRI, FOLFOX, LV5FU2) associated with bevacizumab
Chemotherapy (FOLFIRI, FOLFOX, LV5FU2)