Clinical trial NCT00434252: A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: Avastin
BEAM
Metastatic melanoma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free Survival
timeFrame: From randomization up to102 weeks. As of the clinical cut-off date (April 2009), the maximum time on treatment was 88 weeks, median time was 12.4 weeks for the Placebo arm and 16.1 weeks for the bevacizumab arm.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 102 weeks
measure: Number of Participants With Objective Response
timeFrame: Up to 102 weeks
measure: Percentage of Participants With an Objective Response
timeFrame: Up to 102 weeks
measure: Duration of Objective Response
timeFrame: Up to 102 weeks
measure: Six-month Landmark Survival Rate
timeFrame: 6 months
measure: Twenty-Four Week Landmark Stable Disease
timeFrame: 24 weeks
measure: Number of Participants With Select Adverse Events
timeFrame: Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination.
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Richard Schwartz, M.D.
role: STUDY_DIRECTOR
References: