Trials / Completed
CompletedNCT00111904
Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- Sponsor
- Theradex · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | paclitaxel-loaded polymeric micelle |
Timeline
- Start date
- 2005-05-01
- Primary completion
- 2007-08-01
- First posted
- 2005-05-27
- Last updated
- 2011-12-14
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00111904. Inclusion in this directory is not an endorsement.