Phase I Study Of Gemcitabine, Docetaxel And Carboplatin, With And Without Filrastim Support, Combination Chemotherapy In Patients With Advanced Non-Hematological Malignancies
OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and docetaxel when
administered with carboplatin with or without filgrastim (G-CSF) in patients with advanced
solid tumors. II. Determine a safe dose level and schedule for this regimen for phase II
study in these patients. III. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of docetaxel and gemcitabine. Patients receive
gemcitabine IV over 30 minutes, docetaxel IV over 1 hour, and carboplatin IV over 30 minutes
on day 1. Patients also receive gemcitabine IV over 30 minutes on day 8. Treatment repeats
every 21 days for approximately 6 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and
docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
(DLT). If the DLT is grade 4 neutropenia, filgrastim (G-CSF) is added to the regimen
(administered subcutaneously on days 2-7 and 8-14 or until blood counts recover). A new MTD
is then determined. Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Primary Purpose: Treatment
Chandra P. Belani, MD
University of Pittsburgh
United States: Federal Government
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|