Combination Chemotherapy and Bevacizumab With or Without Bevacizumab Maintenance Therapy in Treating Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given with or without bevacizumab in treating patients with metastatic colorectal cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or without bevacizumab to see how well it works in treating patients with metastatic colorectal cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Bevacizumab; Calcium; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed colorectal cancer

• Metastatic disease

• Not a candidate for curative surgery

• At least 1 tumor target measurable by RECIST criteria

• No metastasis potentially resectable after receiving chemotherapy

• No occlusive tumors

• No macronodular peritoneal carcinomatosis

• No known or suspected CNS metastases

PATIENT CHARACTERISTICS:

• OMS status 0-2

• Life expectancy ≥ 3 months

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9 g/dL

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases)

• Creatinine ≤ 1.5 times ULN

• Proteinuria ≤1 g

• Not pregnant or nursing

• No gastroduodenal ulcer, wound, or fractured bone

• No acute or subacute intestinal occlusion or history of inflammatory bowel disease or large resection of small bowel

• No clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months

• No uncontrolled hypertension while receiving chronic medication

• No other malignancy within the past 5 years except for basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

• No medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study

PRIOR CONCURRENT THERAPY:

• See Patient Characteristics

• No prior chemotherapy for metastatic disease

• Adjuvant chemotherapy allowed provided it was completed > 6 months ago

• No prior irinotecan or other antiangiogenic therapy

• At least 4 weeks since surgery (except for diagnostic biopsy) or irradiation

• No other drugs not allowed for medical reasons

• Concurrent oral anticoagulants (e.g., coumadin, warfarin) allowed provided the INR is closely monitored

• A change of anticoagulants to low-molecular weight heparin is preferred