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

Melanoma (Skin) Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

• NCT number: NCT00081042
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Completion date: January 2010