NCT00081042

ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma

An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with inoperable (unresectable) locally recurrent or metastatic melanoma.

Detailed description

OBJECTIVES: Primary * Determine the antitumor activity of ABI-007 in patients with inoperable locally recurrent or metastatic melanoma. * Determine the safety and tolerability of this drug in these patients. Secondary * Determine the time to disease progression, in terms of the rate and duration of response or stable disease, in patients treated with this drug. * Determine the survival of patients treated with this drug. * Determine the effects of this drug on biomarkers of melanoma in these patients. * Correlate biomarker levels with response in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment cohorts according to prior cytotoxic chemotherapy (previously treated vs chemotherapy-naïve). * Cohort I (previously treated): Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. * Cohort II (chemotherapy-naïve): Patients receive a higher dose of ABI-007 as in cohort I. In both cohorts, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per cohort) will be accrued for this study.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	paclitaxel albumin-stabilized nanoparticle formulation

Timeline

• Start date: 2004-02-01
• Completion: 2010-01-01
• First posted: 2004-04-08
• Last updated: 2013-12-19

Locations

1 site across 1 country: United States