Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00079352|
Recruitment Status : Completed
First Posted : March 10, 2004
Last Update Posted : January 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: alvocidib Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride||Phase 1|
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 solid tumors.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Flavopiridol in Combination With Gemcitabine and Irinotecan in Patients With Metastatic Cancer|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||October 2007|
Experimental: Treatment (gemcitabine, irinotecan, alvocidib)
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.
Other Names:Drug: gemcitabine hydrochloride
Other Names:Drug: irinotecan hydrochloride
- Recommended phase II dose of flavopiridol defined as the highest dose for which no more than one patient develop a >= grade 3 toxicity [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079352
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator:||Ian Rabinowitz||University of New Mexico|