Genentech Halts Trial Testing Avastin in Ovarian Cancer Patients Because 11% Developed Holes in Bowel Lining

Main Category: Ovarian Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 29 Sep 2005 - 0:00 PDT

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San Francisco-based pharmaceutical company Genentech on Friday announced it has stopped enrollment in a Phase II clinical trial testing the colon cancer drug Avastin among ovarian cancer patients after 11% of the patients developed hazardous holes in their stomach and intestinal lining, Reuters reports. Of the 44 patients enrolled in the trial -- which is testing Avastin as an ovarian cancer treatment -- Genentech said they observed five people with potentially fatal holes in their stomach or intestine lining, also known as gastrointestinal perforations. The trial involved ovarian cancer patients whose tumors had spread to other parts of the body and who had not benefited from at least three rounds of chemotherapy (Pierson, Reuters, 9/23). The decision to discontinue enrollment in the trial was made in consultation with FDA, and study investigators were notified of the decision on Friday (Genentech release, 9/23). Company spokesperson Neil Cohen stressed that the testing will be continued with patients who decide that the potential benefits of the drug outweigh the risks (Johnson, San Jose Mercury News, 9/24). He also said Genentech will move forward with plans for a large study of Avastin among women with ovarian cancer but added that the patients will be at an earlier stage of treatment (Tansey, San Francisco Chronicle, 9/24). Testing of the drug -- which is FDA approved for the treatment of colon cancer -- had resulted in few bowel tears in previous trials involving ovarian cancer patients, according to Genentech (Gellene, Los Angeles Times, 9/24). About 100 different clinical trials testing Avastin for different indications are ongoing and about 20 of those involve ovarian cancer patients. Cohen said, "[T]his is the first time I've seen where we've stopped enrollment" (San Jose Mercury News, 9/24). Avastin is the only drug on the market that attacks tumors by starving their blood supply, according to the AP/Chicago Sun-Times (Marchione, AP/Chicago Sun-Times, 9/24).

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