Pancreatic Cancer Research

Clinical trialPhase 2Completed

Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer

Outcome
Finished, no results posted
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
May 2005
Enrollment
43 participants
Sites
5
Primary outcomes
Time to progression; Time to treatment failure; Best overall response rate; Overall survival; Clinical benefit
Sponsor
Industry
Results posted
No
Last update
14 December 2011

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.