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