Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

Completed · Phase 2

Conditions studied: Recurrent Melanoma, Stage IV Melanoma

In brief

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 facts

Study ID

NCT00255762

Run by

National Cancer Institute (NCI)

People needed

47

Starts

2005-12-01

Last updated by the study team

2013-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed melanoma
• Unresectable stage IV disease
• Evidence of metastatic disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No radiologically confirmed invasion of adjacent organs (e.g., duodenum or stomach)
• No tumor invasion of major blood vessels
• No history of primary brain tumor or other CNS disease
• No brain metastases by MRI or CT scan
• Performance status - ECOG 0-2
• More than 4 months
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL (transfusion allowed)
• No active bleeding
• Bilirubin ≤ 1.5 mg/dL
• AST ≤ 3 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3 times ULN
• INR ≤ 1.5 times ULN
• PTT normal
• No known esophageal varices
• Creatinine ≤ 1.5 times ULN
• Urine protein creatinine ratio ≤ 0.5
• Urine protein < 1 g/24-hr urine collection
• No New York Heart Association class II-IV congestive heart failure
• No serious cardiac arrhythmia requiring medication

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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