A Phase 2 interventional study of bevacizumab and fluorouracil in Colorectal Cancer, sponsored by Federation Francophone de Cancerologie Digestive. Completed at 32 sites in France. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by Federation Francophone de Cancerologie Digestive · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with metastatic colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to genotype (UCT1A1*1/ UCT1A1*1 vs UCT1A1*1/ UCT1A1*28).
Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the completion of study therapy.
After completion of study therapy, patients are followed every 2-3 months.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's enrollment of 86 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Federation Francophone de Cancerologie Digestive is the lead sponsor of 61 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of metastatic adenocarcinoma of the colon or rectum
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
No prior chemotherapy for metastatic disease
No oral or parenteral anticoagulant therapy within the past 10 days
Bevacizumab 5 mg/kg D1, irinotecan 260 mg/m2 D1, LV 400 mg/m2 D1, 5FU 400 mg/m2 IV bolus D1, and 5FU 2,400 mg/m2 46-hour infusion D1-2 every 2 weeks. Treatment was started within 2 weeks after inclusion in the study.
Biological: bevacizumab · Drug: fluorouracil · Drug: irinotecan hydrochloride · Drug: leucovorin calcium
Objective response at 6 months by RECIST
Time frame: 6 months
Tolerability evaluated by NCI CTC v. 2.0 criteria
Time frame: From Inclusion
Progression-free and overall survival
Time frame: From Inclusion
Time to treatment failure
Time frame: From Inclusion
Quality of life using the EuroQOL EQ5D questionnaire
Time frame: From Inclusion
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Federation Francophone de Cancerologie Digestive