A Phase I Trial Of Gemcitabine Followed By Flavopiridol In Patients With Solid Tumors
I. Determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with
advanced solid tumors.
II. Determine the toxicity and safety profile of this regimen in these patients.
III. Determine the pharmacokinetic profile of this regimen in this patient population.
OUTLINE: This is a dose-escalation study.
Patients receive gemcitabine IV over 1-2.5 hours on days 1 and 8 and flavopiridol IV
continuously over 24 hours on days 2 and 9. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the
maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 6-58 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Geoffrey Shapiro, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|