A Study of Bevacizumab With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma

NCT00434252 | Completed Phase 2 Results

• 1 other identifier: AVF4096g
• Study Type: interventional
• Target: 214
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melanoma

Keywords

Avastin; BEAM; Metastatic melanoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression-free survival (PFS) was defined as the time from randomization to documented disease progression (at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death on study (death from any cause occurring no later than 30 days after last dose of any study treatment), whichever occurred first, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST). Median PFS was estimated using the Kaplan-Meier method.

  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 (7)

• Overall Survival (OS)

  Up to 102 weeks

• Number of Participants With Objective Response

  Up to 102 weeks

• Percentage of Participants With an Objective Response

  Up to 102 weeks

• Duration of Objective Response

  Up to 102 weeks

• Six-month Landmark Survival Rate

  6 months

Study Arms (2)

Carboplatin+Paclitaxel+Placebo

PLACEBO COMPARATOR

Drug: carboplatin; Drug: paclitaxel; Drug: placebo

Carboplatin+Paclitaxel+Bevacizumab

EXPERIMENTAL

Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel

Interventions

bevacizumab DRUG

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)

Carboplatin+Paclitaxel+Bevacizumab

carboplatin DRUG

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

Carboplatin+Paclitaxel+Bevacizumab; Carboplatin+Paclitaxel+Placebo

paclitaxel DRUG

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)

Carboplatin+Paclitaxel+Bevacizumab; Carboplatin+Paclitaxel+Placebo

placebo DRUG

Administered by IV infusion on the first day of each 3-week cycle

Carboplatin+Paclitaxel+Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Melanoma

Interventions

Bevacizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Richard Schwartz, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2007
• First Posted: February 13, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 18, 2017
• Results First Posted: September 28, 2011

Record last verified: 2017-06