A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and Sorafenib Versus Carboplatin, Paclitaxel and Placebo in Patients With Unresectable Locally Advanced or Stage IV Melanoma
I. To compare the overall survival of patients with unresectable stage III or stage IV
melanoma treated with carboplatin, paclitaxel and placebo versus carboplatin, paclitaxel and
II. To compare progression-free survival, response rate, and safety of patients with
unresectable stage III or stage IV melanoma treated with carboplatin, paclitaxel and placebo
versus carboplatin, paclitaxel and sorafenib.
III. To analyze the pharmacokinetic and pharmacogenetic properties of sorafenib including
angiogenesis, monooxygenases polymorphisms and MDR.
IV. To assess the association of expression markers in the patient tumor with clinical
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over
30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
Arm II: Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral
placebo twice daily on days 2-19.
In both arms, treatment repeats every 21 days for 10 courses in the absence of disease
progression or unacceptable toxicity. Patients with stable disease or who achieve a partial
response or complete response may continue to receive sorafenib or placebo alone twice daily
on days 1-21. Courses with sorafenib or placebo repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.
Survival was assesed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
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