a study of bevacizumab with carboplatin and paclitaxel chemotherapy for the first-line treatment of patients with metastatic melanoma

Conditions: Melanoma

Summary: this phase ii, multicenter, randomized, double-blind, placebo-controlled trial was designed to estimate the efficacy and characterize the safety of bevacizumab when combined with carboplatin + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy alone in patients with previously untreated metastatic melanoma.


Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥ 18 years * metastatic melanoma (stage iv) * histologically confirmed malignant melanoma with measurable or non-measurable disease * ability and willingness to comply with study and follow-up procedures exclusion criteria: * prior treatment for stage iv disease with chemotherapy or biologic therapy such as interferon and interleukin-2 * complete surgical resection or irradiation of all identifiable sites of disease at randomization * radiation therapy within 14 days prior to day 1 * prior therapy with bevacizumab, sorafenib, sunitinib, or other vascular endothelial growth factor (vegf) pathway-targeted therapy * melanoma of ocular origin * known central nervous system (cns) disease/brain metastases (history of brain disease or active disease) * life expectancy of \< 12 weeks * current, recent, or planned participation in an experimental drug study other than a genentech-sponsored bevacizumab cancer study * inadequate organ function * history of other malignancies within 5 years of day 1, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix * any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications * inadequately controlled hypertension * history of hypertensive crisis or hypertensive encephalopathy * new york heart association (nyha) class ii or greater chf * history of myocardial infarction or unstable angina within 6 months prior to day 1 * history of stroke or transient ischemic attack within 6 months prior to day 1 * significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to day 1 * history of hemoptysis within 1 month prior to day 1 * evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 or anticipation of need for major surgical procedure during the course of the study * core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to day 1 * history of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1 * serious, non-healing wound, active ulcer, or untreated bone fracture * known hypersensitivity to any component of bevacizumab * pregnancy (positive pregnancy test) or lactation * current, ongoing treatment with full-dose warfarin

Keywords: avastin beam metastatic melanoma