Clinical Trials Endorsed by the NCCRA for the Prevention and Treatment of Colorectal Cancer

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Last Modified: July 2, 2002

This is a listing of the current trials endorsed by the NCCRA. As new trials are designed and become available, this page will be updated. Also, the database will be evaluated anytime new studies are posted to search for appropriate volunteers that match the studies' criteria. For additional information on these particular trials, please visit the NCCRA website.

1. Breast and Colon Cancer Genetic Study

   Coordinating Investigator: Anil Rustgi, MD
   Study Location: National, multicenter trial
   Sponsor: NCCRA; Based at University of Pennsylvania Cancer Center

   This study is designed to learn more about families with early onset of both breast and colon cancer, especially when diagnosed before the age of 60. Breast and colon cancers are commonly observed in the same family, and we are interested in trying to understand whether there is an underlying genetic susceptibility which links both cancers.

2. Parent and Sibling Genetic Risk Study

   Coordinating Investigators: Sandford Markowitz, MD and Bert Vogelstein, MD
   Study Location: National and coordinated by Case Western Reserve and Johns Hopkins University
   Sponsor: NCCRA

   This study has been designed to look at genetic factors that relate to the development of colon cancer. It is evaluating people with two immediate relatives (a parent, a child or a sibling) who have had colon cancer, with one of those two immediate relatives being under the age of 65. They are also looking for patients with one immediate relative (a parent, a child, or a sibling) who has had colon cancer and was less than 50 years of age when they were diagnosed with the disease.

3. A Phase II, Randomized, Double-Blind, Multicenter Trial of Celecoxib Versus Placebo For The Prevention of Diarrhea Associated With Irinotecan/5-Fluorouracil/Leucovorin Chemotherapy In Patients With Previously Untreated Metastatic Colorectal Cancer

   Study Location: National, Multi-Center
   Sponsor: Pharmacia / Pfizer

   The Diarrhea Prevention with Celecoxib Trial will evaluate whether adding celecoxib to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as CPT-11, Camptosar®), 5-fluorouracil (also known as 5FU), and leucovorin (also known as LV). Laboratory studies suggest that celecoxib may offer an effective means for preventing CPT-11/5FU/LV-induced diarrhea. It is also hypothesized that celecoxib-mediated anti-angiogenesis could induce a favorable tumor response. The study is randomized; therefore patients will have a 50:50 chance of receiving celecoxib.