A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: bevacizumab; carboplatin; paclitaxel; placebo
Intervention description: 15 mg/kg by intravenous (IV) infusion on the first day of each 3-week cycle (dose was based on patient's weight at screening and remained the same throughout study); Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 3-week cycle, for a maximum of 10 cycles; 175 mg/m^2 by IV infusion on the first day of each 3-week cycle (dose was based on patient's weight and could be adjusted for weight change); Administered by IV infusion on the first day of each 3-week cycle
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Avastin; BEAM; Metastatic 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