A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer
I. Determine the maximum tolerated dose and recommended phase II dose of flavopiridol in
combination with gemcitabine and irinotecan in patients with unresectable or metastatic
II. Determine the toxicity profile of this regimen in these patients.
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 30 minutes on
days 1 and 15. Patients also receive flavopiridol IV over 60 minutes on days 2 and 16.
Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose of flavopiridol defined as the highest dose for which no more than one patient develop a >= grade 3 toxicity
University of New Mexico
United States: Food and Drug Administration
|University of New Mexico||Albuquerque, New Mexico 87131|