Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer Read More

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic adenocarcinoma of the colon or rectum

  • Not curable by surgery
• Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/ UGT1A1*28
• Measurable disease
• No original tumor in place
• No secondary cerebral metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

• WHO performance status 0-2
• Life expectancy ≥ 3 months
• Absolute neutrophil count ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• Hemoglobin ≥ 9.0 g/dL
• Total bilirubin ≤ 1.5 times normal
• Alkaline phosphatase ≤ 2.5 times normal (5 times normal if liver involvement)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients of must use effective contraception

Exclusion criteria:

• Progressive gastrointestinal ulcer, hemorrhagic ulcer, or perforation in the past 6 months
• Enteropathy or chronic diarrhea
• Proteinuria > 500 mg/24 hours
• Active cardiac disease
• Uncontrolled hypertension
• Myocardial infarction in the past 12 months
• Angina
• NYHA grade II-IV congestive heart disease
• Severe arrhythmia even with treatment
• Peripheral vascular disease ≥ grade II
• Nonhealing wound, ulcer, or severe bone fracture
• Hemorrhagic diatheses or coagulopathy
• Severe or uncontrolled infection
• Severe or uncontrolled medical condition
• Other malignant disease in the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the uterine cervix
• Severe traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for metastatic disease

  • One prior regimen of chemotherapy in the neoadjuvant or adjuvant setting for the original tumor allowed
• At least 6 months since prior chemotherapy
• No prior irinotecan hydrochloride or bevacizumab

• No oral or parenteral anticoagulant therapy within the past 10 days

  • Warfarin allowed provided INR < 1.5
• No major surgery or biopsy within the past 4 weeks
• No puncture in the past 7 days
• No planned major surgery
• No concurrent daily or chronic aspirin (> 325 mg/day), anti-inflammatories, or steroids
• No other concurrent anticancer therapy