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

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Trial Identification

Brief Title: Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer

Official Title: A Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma

Study ID: NCT00087282

Conditions

Liver Cancer

Interventions

alvocidib

irinotecan hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan and flavopiridol, work in 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: This phase II trial is studying how well giving irinotecan together with flavopiridol works in treating patients with advanced liver cancer.

Detailed Description: OBJECTIVES: Primary * Determine the time to progression in patients with advanced hepatocellular carcinoma treated with irinotecan and flavopiridol. Secondary * Determine the response rate and overall survival in patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label, non-randomized study. Patients receive irinotecan IV over 30 minutes and flavopiridol IV over 1 hour on days 1, 8, 15, and 22. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 16-32 patients will be accrued for this study within 2 years.