Gemcitabine (10 mg/m2/Min) and Cisplatin: A Phase I Study
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of gemcitabine and
cisplatin in patients with metastatic or recurrent nonhematologic malignancies.
OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine IV on
days 1 and 8, followed immediately by cisplatin IV over 2 hours on day 8. Courses repeat
every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 5 patients experience dose limiting toxicity. Patients are followed every 3
months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 18 months.
Primary Purpose: Treatment
Al B. Benson, MD, FACP
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|