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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Description:

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.

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Richard Schwartz, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

AVF4096g

NCT ID:

NCT00434252

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Melanoma
  • Avastin
  • BEAM
  • Metastatic melanoma
  • Melanoma

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