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

About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: 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 No myocardial infarction within the past 6 months No unstable angina within the past 6 months No clinically significant peripheral vascular disease No uncontrolled hypertension (i.e., blood pressure ≥ 150/90 mmHg despite antihypertensive therapy) No clinically significant stroke within the past 6 months No deep vein thrombosis within the past year No other vascular abnormality No pulmonary embolus within the past year No history of abdominal fistula No gastrointestinal perforation No intra-abdominal abscess within the past 4 weeks Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after completion of study therapy No other pathological condition that would confer a high risk of bleeding No active infection requiring parenteral antibiotics No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture No peripheral neuropathy ≥ grade 2 No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs No uncontrolled seizures No other uncontrolled illness No significant traumatic injury within the past 4 weeks No prior antivascular endothelial growth factors (VEGF), including any of the following: Bevacizumab VEGF Trap Anti-VEGF receptor monoclonal antibody Small molecular tyrosine kinase inhibitors of VEGF receptors No more than 1 prior systemic chemotherapy regimen No prior carboplatin or paclitaxel No other concurrent chemotherapy More than 4 weeks since prior radiotherapy No prior radiotherapy to > 25% of bone marrow No concurrent radiotherapy At least 4 weeks since prior major surgical procedure or open biopsy At least 1 week since prior fine-needle aspiration or core biopsy No concurrent major surgery More than 4 weeks since prior systemic therapy No concurrent full-dose oral or parenteral anticoagulation No concurrent antiplatelet therapy except low-dose aspirin (i.e., 81 mg of oral aspirin daily) allowed No other concurrent experimental drugs
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
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.