Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
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 cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining flavopiridol and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer that has not responded to previous paclitaxel therapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Flavopiridol and Paclitaxel in Patients With Paclitaxel-Refractory Esophageal Cancer|
|Study Start Date:||July 2000|
|Study Completion Date:||August 2007|
- Determine the response rate in patients with paclitaxel-refractory locally advanced or metastatic esophageal cancer treated with sequential paclitaxel and flavopiridol.
- Determine the toxicity of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
- Obtain pharmacokinetic information about this regimen.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 3 hours on day 1 and flavopiridol IV continuously over 24 hours on day 2 weekly for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after courses 1 and 2, and then every 2 courses thereafter.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-18 months.
|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|