Clinical trialPhase 2Unknown
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
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Unknown
- Study type
- Interventional
- Start
- June 2001
- Sites
- 9
- Sponsor
- Industry
- Results posted
- No
- Last update
- 18 February 2009
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.