Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma|
|Study Start Date:||June 2004|
|Study Completion Date:||July 2006|
- Determine the time to progression in patients with advanced hepatocellular carcinoma treated with irinotecan and flavopiridol.
- 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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Ghassan Abou-Alfa, MD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Gary K. Schwartz, MD||Memorial Sloan-Kettering Cancer Center|