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A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma
Not Recruiting
Trial ID: NCT00434252
Purpose
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
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Eligibility
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
Intervention(s):
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
6507361234