Phase I Evaluation Of Carboplatin And Gemcitabine
OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and carboplatin in
patients with advanced solid tumors. II. Determine the dose-limiting toxic effects of this
regimen in these patients. III. Evaluate the pharmacokinetics and pharmacodynamics of this
regimen in these patients. IV. Determine the observed responses in these patients receiving
this regimen.
OUTLINE: This is a dose-escalation study of gemcitabine. Patients are stratified according
to prior therapy (no prior chemotherapy and/or prior radiotherapy to less than 20% of bone
marrow vs prior chemotherapy and/or prior radiotherapy to at least 20% of bone marrow).
Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes
on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity. Cohorts of 1-3 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 2 of 3 patients experience dose-limiting toxicity. Patients are followed for
survival.
PROJECTED ACCRUAL: A maximum of 18 patients (9 per stratum) will be accrued for this study.
Interventional
Primary Purpose: Treatment
Corey J. Langer, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000068771
NCT00021346
November 1997
March 2002
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |