DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00024375
- Lead Sponsor
- Theradex
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Kliniken Essen - Mitte
🇩🇪Essen, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Beatson Oncology Centre
🇬🇧Glasgow, Scotland, United Kingdom
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins🇺🇸Baltimore, Maryland, United States