Advanced Colorectal Cancer Patients to Get Expanded Access to Oxaliplatin

The National Cancer Institute has announced it intends to provide expanded access for advanced colorectal cancer patients to the promising chemotherapy drug oxaliplatin even as the U.S. Food and Drug Administration considers approval of it on a Fast Track basis.

The actions followed release of interim results from a multicenter trial showing that oxaliplatin in combination with two other drugs appeared to be significantly more effective than currently used drug combinations in treatment of advanced colorectal cancer (see earlier Colorectal Cancer Week story).

The National Cancer Institute said that based on these results, it has changed the trial. For the next few weeks, new patients will continue to be enrolled in the group using oxaliplatin while control patients not responding to their current treatment will be permitted to switch to the oxaliplatin combination therapy, a spokesperson said.

Then later in June, about 60 cancer centers around the country will begin enrolling advanced colorectal cancer patients in an expanded access program, the National Cancer Institute said.

Due to the limited U.S. supply of oxaliplatin for the next several months, approximately 75 patients eligible for expanded access protocol will be randomly selected by lottery each week to participate, a spokesperson said.

Details about enrolling either in the current clinical trial or in the expanded access protocol are available by calling the NCI's Cancer Information Service at 1-800-4-CANCER.

News of the National Cancer Institute's actions was hailed by colorectal cancer patient advocates.

"The trial results show that oxaliplatin is a valuable new weapon for colon cancer patients to add to their arsenals, and the expanded access programs will let them use it sooner rather than later," said Priscilla Savary, executive director of the Colorectal Cancer Network.

"These expanded access programs provide a vital treatment option to people with advanced colorectal cancer who are out of approved treatments," said Kevin Lewis, chair of the Colon Cancer Alliance.

Meanwhile, Sanofi Pharmaceuticals said the FDA has agreed to consider oxaliplatin under the Fast Track review process in light of the new data. Sanofi said it hoped to get a submission for oxaliplatin to the FDA during June. While the drug has been used in Europe for several years, the FDA asked for more data when it rejected the drug in 2000 because the European trials did not follow U.S. guidelines.

Other sources: NCI, FDA, Sanofi