Conditions: Melanoma
Keywords: Avastin BEAM Metastatic melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 214
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: bevacizumab intervention 2: carboplatin intervention 3: paclitaxel intervention 4: placebo
Intervention descriptions: intervention 1: 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) intervention 2: 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 intervention 3: 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) intervention 4: Administered by IV infusion on the first day of each 3-week cycle

Protocol document: