NCT01175291

FOLFOX/Bevacizumab +/- MK-0646 in Metastatic Colorectal Cancer

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to study the efficacy (effectiveness) of a new drug, MK-0646, in metastatic colorectal cancer. MK-0646 is an investigational or experimental anti-cancer agent that has not yet been approved by the U.S. Food and Drug Administration (FDA) for use in metastatic colorectal cancer or any other disease. This study will assess whether adding MK-0646 to an FDA-approved standard of care chemotherapy improves participants' duration of progression-free survival. MK-0646 is believed to inhibit the receptor of a protein called IGF-1 (Insulin-like Growth Factor) which is thought to contribute to cancer development and growth. However, there is no guarantee that MK-0646 will slow cancer development and growth. Other purposes of this study include: * looking at the safety and tolerability of MK-0646 * comparing MK-0646 + standard of care chemotherapy with placebo + standard of care chemotherapy (placebo is a substance that looks like an active drug but has no active ingredient) The standard of care chemotherapy in this study is called FOLFOX 7. FOLFOX 7 includes the drugs oxaliplatin with leucovorin, 5-Fluorouracil (5-FU), and bevacizumab.

Detailed description

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).

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	MK-0646	ARM A will receive FOLFOX 7 (Oxaliplatin with leucovorin + 5-Fluorouracil \[5-FU\] + Bevacizumab) + MK-0646 (Investigational).
DRUG	Placebo	ARM B will receive FOLFOX 7 (Oxaliplatin with leucovorin + 5-Fluorouracil \[5-FU\] + Bevacizumab) + placebo: standard of care chemotherapy plus placebo.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-08-04
• Last updated: 2011-12-05