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

ClinicalTrials.gov ID: NCT00462423

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00462423
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Lynn E. Spitler, MD; Other
Enrollment: 50 participants

Conditions and interventions

Conditions

Metastatic Malignant Melanoma

Interventions

Avastin Drug
Abraxane Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 2007 (Type not available)
Primary completion: Apr 2011 (Actual)
Completion: Jan 2012 (Actual)
Last update posted: Jan 8, 2014

2007 – 2012

United States locations

U.S. sites: 2
U.S. states: 1
U.S. cities: 2

Facility	City	State	ZIP	Site status
Northern California Melanoma Center	San Francisco	California	94117	—
The Angeles Clinic and Research Institute	Santa Monica	California	90404	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00462423, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 8, 2014 · Synced Nov 15, 2026