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Brief Title: Study to Identify Mechanisms of Resistance to Standard Therapy in Patients With Metastatic Colorectal Cancer
Official Title: Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Standard First-line Therapy in Patients With Metastatic Colorectal Cancer
Study ID: NCT00984048
Brief Summary: This is a multicenter translational study to understand therapeutic resistance in patients undergoing first-line chemotherapy (FOLFOX/Avastin, or FOLFIRI/Avastin) for metastatic colorectal cancer. Tissue samples from liver metastasis will be collected and banked before the start of chemotherapy and at the time of progression. Additionally, blood samples will be drawn monthly and stored in the tissue biobank.
Detailed Description: The major obstacle to the cure of cancer by pharmacological agents is resistance to these agents. Clinical responses of metastatic cancers to the most advanced chemotherapeutic agents usually range from 15 to 40%, indicating that intrinsic resistance, and acquired resistance occurs almost inevitably in those tumors that do respond. In patients with metastatic colorectal cancer, clinical resistance to a particular treatment is a clear endpoint (tumor growth), and is usually observed within 6-12 months of any given therapy. Thus, drug resistance and selecting appropriate therapeutic alternatives for drug-resistant cancer remain major dilemmas for oncologists. The current first-line treatment for metastatic colorectal cancer in Quebec and much of North America is a combination called FOLFOX (the fluoro-pyrimidine 5-FU given as a 46-hour infusion, folinic acid and oxaliplatin) in combination with bevacizumab (Avastin庐). An alternative regimen of cytotoxic drugs, also used with Avastin庐, is FOLFIRI, which simply replaces oxaliplatin with the topoisomerase inhibitor irinotecan. In the metastatic setting, studies have not demonstrated significant differences between the two regimens, such that decision-making lacks definitive tools. The objective of this study is to identify, in clinical samples, the molecular signature of clinically resistant colorectal cancer (CRC) patients for the most current and commonly used therapeutic agents. The goals of this study are two-fold. First, to build a biobank of blood and tissue specimens, prior to starting chemotherapy and at a determined time-point (progression of disease), from patients undergoing the same standard and well established first-line treatments (FOLFOX/bevacizumab or FOLFIRI/bevacizumab) for metastatic colorectal cancer. Second, to use state-of-the-art approaches by various collaborating laboratories to correlate clinical outcomes with molecular events that can be used to predict and circumscribe chemoresistance.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital Leuven, Leuven, , Belgium
The Moncton Hospital, Moncton, New Brunswick, Canada
Dr. Georges L. Dumont University Hospital, Moncton, New Brunswick, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
H么pital Charles Lemoyne, Greenfield Park, Quebec, Canada
H么pital Maisonneuve-Rosemont, Montreal, Quebec, Canada
H么pital Notre-Dame, Montreal, Quebec, Canada
H么pital Saint-Luc, Montreal, Quebec, Canada
Royal Victoria Hospital, Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
St-Mary's Hospital, Montreal, Quebec, Canada
McGill University Health Centre, Montreal, Quebec, Canada
H么pital Sacr茅-Coeur, Montreal, Quebec, Canada
H么tel-Dieu du Qu茅bec, Qu茅bec, Quebec, Canada
Name: Gerald Batist, MD
Affiliation: Jewish General Hospital, Segal Cancer Center
Role: STUDY_DIRECTOR