Trial Search Results
A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma
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.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Genentech, Inc.
Stanford Investigator(s):
Intervention(s):
- Drug: bevacizumab
- Drug: carboplatin
- Drug: paclitaxel
- Drug: placebo
Phase:
Phase 2
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sunil Arani Reddy
6507361234
Not Recruiting