Researchers Report Phase I Results For Aptosyn™ Plus CPT-11

Researchers from Georgetown University reported encouraging Phase I results in their test of Aptosyn™ (exisulind) plus CPT-11 (Camptosar®, Irinotecan) in 14 patients with colorectal cancer and other solid tumors who had failed at least two prior chemotherapy regimens.

The researchers told an international meeting of the American Association of Cancer Research that the study showed the drug combination to be generally well tolerated by patients at doses up to and including 250 mg Aptosyn twice daily and 125 mg/m2 CPT-11.

"Aptosynand CPT-11 work through different, complementary mechanisms of action and appear to lack overlapping toxicities that might otherwise greatly limit their combined use," said Dr. John L. Marshall. "We are extending our investigation to accrue additional patients who will receive escalating doses of CPT-11 while maintaining Aptosyn at 250 mg bid based on the lower than anticipated toxicity observed to date for this combination regimen."

"CPT-11 is known to have significant clinical activity on its own in colon and a variety of other cancers, and preclinical research has demonstrated synergistic anticancer activity between Aptosyn and CPT-11," said Dr. Rifat Pamukcu, chief scientific officer at Cell Pathways. "We hope to further demonstrate an enhanced anticancer activity in humans on the molecular basis by analyzing changes in apoptosis pathways in response to treatment in tumor and normal tissues from the new patients enrolled in this extended study.

CPT-11 is approved by the U.S. Food and Drug Administration (FDA) for the first and second-line treatment of advanced colorectal cancer.

Other Sources: Cell Pathways