Multicenter Phase III Randomized Study of FOLFIRI Plus Bevacizumab Following or Not by a Maintenance Therapy With Bevacizumab in Patients With Non-Pretreated Metastatic Colorectal Cancer
- Compare disease-control duration in patients with metastatic colorectal cancer
receiving FOLFIRI chemotherapy in combination with bevacizumab with or without
bevacizumab maintenance therapy.
- Determine objective response rate.
- Determine non-hematologic grade 3-4 (except alopecia) toxicity rate.
- Determine overall toxicity rate.
- Determine duration of chemotherapy-free interval.
- Determine progression-free survival.
- Determine overall survival.
- Determine time-to-treatment failure.
- Determine quality of life (EORTC QLQ-C30).
- Complete geriatric evaluation.
OUTLINE: This is a multicenter study. Patients are stratified according to cancer center,
primary tumor (resected vs unresected), and Köhne criteria (low vs intermediate vs high).
Patients are randomized to 1 of 2 treatment arms.
- Arm A: Patients receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV
over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV
over 46 hours on days 1-2. Chemotherapy treatment repeats every 2 weeks for 12 courses.
Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks during
chemotherapy. Patients then receive bevacizumab maintenance therapy once every 2 weeks
during the chemotherapy-free interval.
- Arm B: Patients receive FOLFIRI chemotherapy and bevacizumab as in arm A. Patients
receive no treatment during the chemotherapy-free interval.
In all arms, the chemotherapy treatment and the chemotherapy-free interval treatment repeats
in the absence of disease progression during the chemotherapy portion or unacceptable
toxicity. Patients who progress during the chemotherapy-free interval will receive 12 more
courses of chemotherapy.
All patients complete quality of life questionnaires (QLQ-30) and patients ≥ 75 also
complete the geriatric questionnaire at baseline and every 8 weeks during study treatment.
After completion of study treatment, patients are followed up every 8 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
one year after last patient included
Hopital Avicenne BOBIGNY
France: Agence Nationale de Sécurité du Médicament et des produits de santé