Trials / Unknown
UnknownNCT00024375
DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
Phase II Open-Label Study of Taxoperxin (DHA-Paclitaxel) Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Theradex · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DHA-paclitaxel |
Timeline
- Start date
- 2001-06-01
- First posted
- 2003-01-27
- Last updated
- 2009-02-18
Locations
9 sites across 4 countries: United States, Germany, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT00024375. Inclusion in this directory is not an endorsement.