Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Part of paid clinical trials in Rochester, Minnesota.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00255762
- Phase
- PHASE2
- Status
- Completed
Conditions
- Recurrent Melanoma
- Stage IV Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- carboplatin — DRUGGiven IV
- paclitaxel — DRUGGiven IV
- bevacizumab — BIOLOGICALGiven IV
- laboratory biomarker analysis — OTHERCorrelative studies
Study Details
This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells.
Key Dates
- First listed
- Nov 21, 2005
- Start date
- Dec 31, 2005
- Status verified
- Oct 2013
- Primary completion
- Dec 31, 2006
Study Design
- Enrollment
- 47 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (carboplatin, paclitaxel, bevacizumab)Patients receive carboplatin IV over 30 minutes on day 1, paclitaxel IV over 1 hour on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Progression free survival [ Time Frame: Time from registration to documentation of disease progression, assessed up to 8 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Central Cancer Treatment Group | Rochester | Minnesota | 55905 | - |
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