MANHASSET, New YorkEarly results from a phase I trial at
North Shore University Hospital, Manhasset, New York, found irinotecan
(CPT-11, Camptosar) with 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
"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 or
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.