Conditions: Colorectal Cancer
Keywords: Colorectal Cancer Axitinib FOLFOX/Bevacizumab
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 70
Healthy volunteers: no

Brief summary:
This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC.

Detailed description:
All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started. With approval of the Medical Monitor,patients who are having significant benefit from FOLFOX/bevacizumab may continue chemotherapy to a maximum of six 28-day cycles. During trial treatment, all patients will be assessed for response every 8 weeks (2 cycles).

Arms:
arm 1: Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC. (FOLFOX is a combination of 5-Fluorouracil, Leucovorin and Oxaliplatin.)

All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started.

Interventions: intervention 1: Axitinib intervention 2: Bevacizumab intervention 3: 5-Fluorouracil intervention 4: 5-Fluorouracil intervention 5: Leucovorin intervention 6: Oxaliplatin
Intervention descriptions: intervention 1: 5-mg tablets PO BID intervention 2: 5 mg/kg Days 1 and 15; IV intervention 3: 400 mg/m2 Days 1 and 15; IV intervention 4: 2400 mg/m2 over 46-48 hours Days 1 and 15; Continuous Intravenous intervention 5: 400 mg/m2 Days 1 and 15; IV intervention 6: 85 mg/m2 Days 1 and 15; IV

Protocol document: