DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00024375|
Recruitment Status : Unknown
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 18, 2009
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 DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: DHA-paclitaxel||Phase 2|
- Determine the tumor response rate, duration of response, and time to disease progression in patients with metastatic carcinoma of the pancreas treated with DHA-paclitaxel.
- Determine the overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- Assess the quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 2 courses, and at completion of treatment.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Open-Label Study of Taxoperxin (DHA-Paclitaxel) Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas|
|Study Start Date :||June 2001|
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): NCT00024375
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|United States, Pennsylvania|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Kliniken Essen - Mitte|
|Essen, Germany, D-45136|
|Frankfurt, Germany, D-60488|
|Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 EA|
|New Cross Hospital|
|Wolverhampton, England, United Kingdom, WV10 0QP|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Ross C. Donehower, MD||Sidney Kimmel Comprehensive Cancer Center|