An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma
- 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.
- 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
- 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
In both cohorts, courses repeat every 4 weeks in the absence of disease progression or
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
Masking: Open Label, Primary Purpose: Treatment
Antoni Ribas, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|