Conditions: Metastatic Melanoma
Keywords: Metastatic Melanoma Everolimus Paclitaxel Carboplatin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 70
Healthy volunteers: no

Brief summary:
Based on data demonstrating synergy between paclitaxel and mammalian target of rapamycin (mTOR) inhibition, the investigators propose that the addition of everolimus to paclitaxel with carboplatin should lead to improvements in efficacy as measured by progression-free survival and response rate.

Detailed description:

Arms:
arm 1: Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle

Interventions: intervention 1: Paclitaxel intervention 2: Carboplatin intervention 3: Everolimus
Intervention descriptions: intervention 1: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle intervention 2: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle intervention 3: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle

Protocol document: