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Abraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study

NCT00462423 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-01-08

Study results available
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Summary

The study is an open-label, single arm multicenter Phase II study to evaluate the safety and efficacy of the combination of Abraxane and Avastin as first-line therapy for patients with unresectable metastatic malignant melanoma. The patient sample will be approximately 50 individuals, males and females 18 years of age or older with measurable metastatic melanoma.

Patients will be treated with Abraxane administered weekly for 3 weeks via a 30-minute IV infusion at150 mg/m2 followed by 1 week rest (28-day cycle). Avastin will be administered in a dose of 10 mg/kg every 2 weeks (without rest period). Patients will be evaluated for disease progression every 2 months and those who do not have disease progression or unacceptable toxicity will be offered ongoing therapy until they have progressive disease or unacceptable toxicity.

Conditions

  • Metastatic Malignant Melanoma

Interventions

DRUG

Avastin

Avastin 10 mg/kg IV every 2 weeks (without rest period).

DRUG

Abraxane

Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Lynn E. Spitler, MD

    lead OTHER

Principal Investigators

  • Lynn E. Spitler, MD · Northern California Melanoma Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-04-30
Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00462423 on ClinicalTrials.gov