FOLFOX/Bevacizumab +/- MK-0646 in Metastatic Colorectal Cancer
Status:
Withdrawn
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute