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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Florida Cancer Specialists - Bonita Springs
Bonita Springs, Florida, United States
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, United States
Louisiana Oncology Associates - Lafayette
Lafayette, Louisiana, United States
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, United States
Time to progression
Time to treatment failure
Best overall response rate
Overall survival
Clinical benefit
Safety
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Southwest Regional Cancer Center - Central
Austin, Texas, United States