Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00111904|
Recruitment Status : Completed
First Posted : May 27, 2005
Last Update Posted : December 14, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: paclitaxel-loaded polymeric micelle||Phase 2|
- 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 (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||August 2007|
- Time to progression
- Time to treatment failure
- Best overall response rate
- Overall survival
- Clinical benefit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111904
|United States, Florida|
|Florida Cancer Specialists - Bonita Springs|
|Bonita Springs, Florida, United States, 34135|
|United States, Illinois|
|Midwest Cancer Research Group, Incorporated|
|Skokie, Illinois, United States, 60077|
|United States, Louisiana|
|Louisiana Oncology Associates - Lafayette|
|Lafayette, Louisiana, United States, 70506|
|United States, New York|
|St. Vincent's Comprehensive Cancer Center - Manhattan|
|New York, New York, United States, 10011|
|United States, Texas|
|Southwest Regional Cancer Center - Central|
|Austin, Texas, United States, 78705|
|Study Chair:||John S. MacDonald, MD||Beth Israel Comprehensive Cancer Center - West Side Campus|