Trials / Completed
CompletedNCT00217607
Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
Multicentric Phase II Study Evaluating the Efficacy and Toxicity of Weekly Paclitaxel in Locally Advanced or Metastatic Soft Tissue Angiosarcomas That Cannot be Treated by Surgery
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- UNICANCER · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 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 locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery.
Detailed description
OBJECTIVES: Primary * Determine the 2-month objective response rate in patients with locally advanced or metastatic, unresectable soft tissue angiosarcoma or lymphangiosarcoma treated with paclitaxel. Secondary * Determine the 4- and 6-month response rate in patients treated with this drug. * Determine tolerability of this drug in these patients. * Determine the time to disease progression and overall survival of patients treated with this drug. * Determine the clinical criteria predicting response in patients treated with this drug. * Correlate the efficacy of this drug with the expression of genes involved in angiogenesis regulation in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | paclitaxel |
Timeline
- Start date
- 2005-02-01
- Primary completion
- 2008-04-01
- Completion
- 2012-01-01
- First posted
- 2005-09-22
- Last updated
- 2016-08-30
Locations
23 sites across 1 country: France
Source: ClinicalTrials.gov record NCT00217607. Inclusion in this directory is not an endorsement.