MANHASSET, New YorkEarly results from a phase I trial at North Shore University Hospital, Manhasset, New York, found irinotecan(Drug information on irinotecan) (CPT-11, Camptosar) with capecitabine(Drug information on capecitabine) (Xeloda) to be well tolerated by patients with inoperable or metastatic solid tumors who had failed standard therapy or had no therapy options, according to an abstract published at the American Society of Clinical Oncology annual meeting (abstract 2127).
"This is one of several trials that are looking at Xeloda combinations," said Daniel R. Budman, MD, professor of medicine, New York University School of Medicine. "The advantages of Xeloda are that it offers continuous exposure and concentrates in the tumor."
Researchers designed the trial to incorporate recent preclinical evidence indicating that irinotecan upregulates thymidine phosphorylase, a critical enzyme in capecitabine activation and tumor targeting. Dosages and scheduling were based on xenograft models showing synergism when irinotecan is given first with a 24-hour delay before starting capecitabine.
"This is the closest trial to the xenograft mouse data, which comes from Drs. S. Cao and Y. Rustum of Roswell Park Cancer Institute. They showed curative potential if you give irinotecan on day 1 then wait 24 hours before using capecitabine," Dr. Budman said.
Patients with inoperable or metastatic solid tumors who had failed standard therapy or did not have a therapy option were enrolled. Eligibility criteria include performance scores of 0 to 2, age 18 or older, normal organ function, and no prior treatment with fluorouracil(Drug information on fluorouracil) or irinotecan.
The trial has enrolled 16 patients to date, 8 male and 8 female. They range in age from 40 to 76 years. Thirteen had received prior chemotherapy, and four radiation therapy.