1st Line Chemotherapy Alone or With Bevacizumab in Treating Older Patients With Metastatic Colorectal Cancer

Sponsor
Federation Francophone de Cancerologie Digestive
Study ID
NCT01417494
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
75 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, 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. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. It is not yet known whether combination chemotherapy is more effective when given together with or without bevacizumab in treating patients with colorectal cancer. PURPOSE: This randomized phase II trial is studying the side effects of giving bevacizumab together with first-line chemotherapy and to see how well it works in treating older patients with metastatic colorectal cancer.

Key Dates

First listed
Aug 16, 2011
Start date
Jul 31, 2011
Status verified
Oct 2020
Primary completion
Sep 30, 2014
Completion
Apr 30, 2016

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy associated with bevacizumab
    Chemotherapy (FOLFIRI, FOLFOX, LV5FU2) associated with bevacizumab
  • Active Comparator: Chemotherapy
    Chemotherapy (FOLFIRI, FOLFOX, LV5FU2)

Primary Outcome Measure

Efficacy, in terms of objective response or tumoral stability by RECIST criteria [ Time Frame: 4 months ]

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