Study: Vioxx Not Seen Aiding Chemotherapy for Advanced Colorectal Cancer

Vioxx, a drug commonly prescribed to relieve arthritis pain, does not appear to enhance chemotherapy in fighting advanced colorectal cancer and results in increased gastrointestinal toxicity, according to a report in the International Journal of Cancer.

The findings by University of Texas Southwestern Medical Center researchers follow an earlier report by Boston University researchers that low doses of Vioxx -- a member of the newest class of nonsteroidal anti-inflammatory drugs (NSAIDs) known as a COX-2 inhibitor -- shrank tumors in the mice (see earlier Colorectal Cancer Week story)..

In their study, the Texas researchers gave patients with metastatic colorectal cancer Vioxx (rofecoxib) in addition to the chemotherapy drug 5-FU and Leucovorin, the active form of the B complex vitamin, folate.

"There were no partial or complete responses in the first 10 patients entered on the study so the study was terminated," the researchers reported.

But beyond the lack of response, four patients entered on the study developed upper gastrointestinal bleeding , three developed grade II stomatitis (3 patients), one developed grade II thrombocytopenia, two had grade II diarrhea and one had grade I nausea.

"Rofecoxib did not appear to increase antitumor activity and resulted in increased gastrointestinal toxicity when combined with 5-FU and Leucovorin," the researchers concluded. "Future studies will need to consider the added gastrointestinal toxicity of Rofecoxib when combined with chemotherapy for the treatment of patients with colorectal cancer."

Other Sources: International Journal of Cancer