Randomized, Double Blind Phase II Study of FOLFOX/Bevacizumab Combined With MK-0646 Versus FOLFOX/Bevacizumab Combined With Placebo in First-Line Treatment of Metastatic Colorectal Cancer
Participants randomized to ARM A will receive modified FOLFOX 7 every other week + MK-0646
every week:
5-FU 400 mg/m2 by intravenous infusion over 2-5 minutes Leucovorin 400 mg/m2 by intravenous
infusion over 2 hours Oxaliplatin 85 mg/m2 by intravenous infusion over 2 hours (with
leucovorin) Bevacizumab 5 mg/kg by intravenous infusion over 30 minutes (+/- 15 minutes)
following infusions may be given over 10 minutes (+/- 10 minutes) if the first infusion is
tolerated well.
5-FU 2400 mg/m2 by continuous intravenous infusion over 46 hours (may be delivered via
automated outpatient pump) Antiemetics (drugs that prevent nausea and vomiting): 5-HT3
receptor antagonist (e.g. ondansetron) and dexamethasone are recommended prior to
chemotherapy.
MK-0646 10 mg/kg by intravenous infusion over 60 minutes every week (participants larger
than 100 kg [220 pounds] will receive their infusions over 120 minutes).
Participants randomized to ARM B will receive modified FOLFOX 7 every other week + placebo
every week:
5-FU 400 mg/m2 by intravenous infusion over 2-5 minutes Leucovorin 400 mg/m2 by intravenous
infusion over 2 hours Oxaliplatin 85 mg/m2 by intravenous infusion over 2 hours (with
leucovorin) Bevacizumab 5 mg/kg by intravenous infusion over 30 minutes (+/- 15 minutes);
following infusions may be given over 10 minutes (+/- 10 minutes) if the first infusion is
tolerated well.
5-FU 2400 mg/m2 by continuous intravenous infusion over 46 hours (may be delivered via
automated outpatient pump) Antiemetics: 5-HT3 receptor antagonist (e.g. ondansetron) and
dexamethasone are recommended prior to chemotherapy Placebo by intravenous infusion over 60
minutes every week (participants larger than 100 kg [220 pounds] will receive their
infusions over 120 minutes).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression Free Survival
To determine whether the administration of MK-0646 with FOLFOX and bevacizumab (experimental arm) improves progression-free survival (PFS) versus FOLFOX and bevacizumab combined with placebo (control arm).
Average of 12 months
No
United States: Food and Drug Administration
MCC-16145
NCT01175291
September 2010
July 2012
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