A Phase I Study of Oral Fluoropyrimidine Capecitabine (Xeloda Roche) Combined With Intravenous Cisplatin in Patients With Advanced Cancer of the Digestive System
- Determine the dose-limiting toxicity, maximum tolerated dose, and the recommended phase
II dose of capecitabine and cisplatin in patients with locally advanced or metastatic
cancer of the upper gastrointestinal tract (GI), head and neck, lung, breast, or
carcinoma of unknown primary.
- Determine the toxic effects of this regimen in these patients.
- Evaluate possible antitumor effectiveness of this regimen in these patients.
- Determine the toxic effects of cisplatin and capecitabine at the recommended phase II
dose in patients with cancer of the upper GI tract.
- Determine the overall survival, time to progression, and duration of response in
patients treated with this regimen.
OUTLINE: This is a dose-escalation study of capecitabine.
Patients receive oral capecitabine twice daily for 5, 10, or 14 days. Patients also receive
cisplatin IV on day 1 of each course. Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients
experience dose-limiting toxicity (DLT). The recommended phase II dose is defined as the
dose preceding the MTD, provided no more than 3 of 12 patients experience DLT at that dose.
Twenty additional patients with cancer of the upper gastrointestinal tract receive treatment
with cisplatin and capecitabine at the recommended phase II dose for at least 6 months in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20-50 patients will be accrued for this study within 1-3
Primary Purpose: Treatment
Franco M. Muggia, MD
New York University School of Medicine
United States: Federal Government
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|