Spots Global Cancer Trial Database for Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors

Official Title: An Open-Labeled, Non-Randomized Phase I Study Of Flavopiridol Administered With Irinotecan (CPT-11) In Patients With Advanced Solid Tumors

Study ID: NCT00006485

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

alvocidib

irinotecan hydrochloride

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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.