A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma

Not Recruiting

Trial ID: NCT00434252


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.

Official Title

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma

Stanford Investigator(s)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology


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

   - 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

   - 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


drug: bevacizumab

drug: carboplatin

drug: paclitaxel

drug: placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sunil Arani Reddy

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