Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with irinotecan in treating patients who have locally advanced or metastatic solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Labeled, Non-Randomized Phase I Study Of Flavopiridol Administered With Irinotecan (CPT-11) In Patients With Advanced Solid Tumors|
|Study Start Date:||September 2000|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of flavopiridol when combined with irinotecan in patients with advanced solid tumors.
- Determine the clinical pharmacokinetics of this regimen, as well as the plasma levels of the active metabolite SN-38 and metabolic product SN-38 glucuronide in these patients.
- Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients.
- Determine the role of p21 relative to treatment response and apoptosis in these patients treated with this regimen.
OUTLINE: This is a dose-escalation, open-label, non-randomized study of flavopiridol.
Patients receive irinotecan IV over 30 minutes followed 7 hours later by flavopiridol IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. During the first week of the second course, patients receive flavopiridol alone on day 1 and irinotecan alone on day 2.
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 or more of 6 patients in the initial cohort experience dose limiting toxicity during the first course of treatment. An additional 10 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 44-50 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006485
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Gary K. Schwartz, MD||Memorial Sloan Kettering Cancer Center.|