Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00111904
- Lead Sponsor
- Theradex
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.
- Detailed Description
OBJECTIVES:
* Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol\^®-PM).
* Determine the best overall response rate and duration of response in patients treated with this drug.
* Determine the overall survival of patients treated with this drug.
* Determine the clinical benefit and safety of this drug in these patients.
OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol\^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to progression Time to treatment failure Best overall response rate Overall survival Clinical benefit Safety
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
St. Vincent's Comprehensive Cancer Center - Manhattan
🇺🇸New York, New York, United States
Midwest Cancer Research Group, Incorporated
🇺🇸Skokie, Illinois, United States
Southwest Regional Cancer Center - Central
🇺🇸Austin, Texas, United States
Louisiana Oncology Associates - Lafayette
🇺🇸Lafayette, Louisiana, United States
Florida Cancer Specialists - Bonita Springs
🇺🇸Bonita Springs, Florida, United States