BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have advanced pancreatic cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer|
|Study Start Date:||July 2001|
|Study Completion Date:||April 2006|
- Determine the 6-month survival rate and time to treatment failure in patients with advanced pancreatic adenocarcinoma treated with BMS-247550.
- Determine the frequency and severity of toxic effects of this drug in these patients.
- Determine the complete and partial response in those patients with measurable disease treated with this drug.
- Determine the pharmacokinetic profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 6 months for 2 years and then annually until 3 years after registration.
PROJECTED ACCRUAL: A total of 25-55 patients will be accrued for this study.