Important colorectal cancer clinical trial continues

Tuesday, May 21, 2002

JACKSONVILLE, Fla., May 21, 2002 — Researchers at Mayo Clinic in Jacksonville are still enrolling eligible patients with advanced colorectal cancer in an important clinical trial evaluating the efficacy and safety of different combinations of drugs, including the investigational drug oxaliplatin. Last month, leadership of the Phase III, multi-center study, known as N9741, discontinued patient enrollment to the control arm of this trial. Their preliminary data analysis showed patients receiving the treatment regimen known as FOLFOX, which contains oxaliplatin, appeared to have fared much better than patients receiving the study's standard treatment known as IFL.

Patients receiving the FOLFOX regimen experienced significantly longer time to disease progression, significantly better overall survival, significantly higher response rate and lower toxicity than did patients receiving the IFL regimen.

"All new patients, including those enrolling at Mayo Clinic, will only be enrolled in the FOLFOX arm of this trial," says Mayo Clinic oncologist Dr. Edith Perez. "In addition, patients already receiving treatment in the control arm, as well as all previously closed arms of the study, are being given the option of remaining on their current treatment or switching to the FOLFOX arm of the study."

Perez is director of the Cancer Clinical Study Unit and principal investigator for the North Central Cancer Treatment Group (NCCTG) at Mayo Clinic in Jacksonville. The NCCTG is the National Cancer Institute (NCI) clinical trials cooperative group coordinating this study.

The FOLFOX regimen consists of oxaliplatin infusion followed by infusion of 5-flourouracil and Leucovorin. Oxaliplatin has already been approved for use in France and the United Kingdom, but has not yet been approved for use in the United States by the Food and Drug Administration (FDA). It is currently available only to cancer patients in the United States who are enrolled in clinical trials such as N9741.

Dr. George Kim, leader of the Gastrointestinal Tumor Group at Mayo Clinic, views the study's new finding as a significant improvement in the management of patients with advanced colorectal cancer. He notes that because of the encouraging data from N9741, the FDA, the NCI and the drug manufacturer are discussing ways to make oxaliplatin available off-study to patients with advanced colorectal cancer.

Patients with locally advanced, locally recurrent or metastatic colorectal cancer who have not received any prior chemotherapy for advanced colorectal cancer may be eligible to enroll in N9741. Interested patients may call (904) 953-2946 for additional eligibility requirements.

Media contact: Erik Kaldor 904-953-2299

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