A Study of Bevacizumab and Modified FOLFOX-6 (mFOLFOX-6) in Participants With Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2016-05-18
Target enrollment:
Participant gender:
Summary
The multicenter, open-label, single-arm, non-randomized, two-stage Simon's design, phase II
study (The CLMO-001 Trial) will evaluate the efficacy and safety of bevacizumab in
combination with mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU] and oxaliplatin) in
participants with colorectal cancer and liver metastases. Participants will receive
combination therapy of bevacizumab 5 milligrams per kilogram (mg/kg) intravenous (IV) dose
and mFOLFOX-6 every 2 weeks during Cycles 1-5 and Cycles 7-12. Participants will receive
mFOLFOX-6 alone (without bevacizumab) on Cycle 6. In between Cycle 6 and 7, participants will
undergo liver surgery if operable. Thereafter participants will receive bevacizumab (5 mg/kg
IV every 2 weeks) alone for 52 weeks (26 cycles) after the end of the post-operative phase
(maintenance therapy). At the end of the preoperative treatment phase (Cycles 1-6),
participants showing different alternative conditions admitted by the protocol will undergo
different management (alternative study designs 1 to 3).