A Study of Systemic Hedgehog Antagonist With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer
Patients are being recruited for a randomized Phase II clinical trial to test a new drug — GDC-0449 – for the initial treatment of metastatic colon and rectal cancer.
GD-0449 is an agent that blocks the “hedgehog” molecular signal in cancer cells. Hedgehog signals lead to tumor growth by encouraging cells to divide and accumulate without control.
The clinical trial will be testing whether adding GDC-0449 increases the time before the cancer progresses — progression-free survival. It will also be assessing side effects in both arms of the trial. Hedgehog expression in tumor tissue will be studied as well.
Patients will be randomly assigned to receive either:
- Standard of care first-line treatment for metastatic colorectal cancer: Either FOLFOX or FOLFIRI plus Avastin (bevacizumab).
- Standard FOLFOX or FOLFIRI plus Avastin plus the investigational hedgehog antagonist GDC-0449.
To be eligible patients must
- Have confirmed colon or rectal cancer that has spread in the body (metastatic).
- Not have been previously treated for metastatic colorectal cancer or received adjuvant chemotherapy within the past six months.
- Have specimens of their tumors available in paraffin blocks before beginning the trial for study.
- Have good performance status
- Have good liver and kidney function and blood counts.
For more information about the trial, you can contact Lisa Nelson
nelson.lisa@gene.com or one of the centers where the trial is being held.
Find a center where patients are being recruited.
ClinicalTrials.gov identifier: NCT00636610
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