Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
- To estimate the non-comparative efficacy of sulindac and epirubicin hydrochloride in
patients with metastatic malignant melanoma.
- To characterize the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sulindac 2 hours prior to receiving epirubicin hydrochloride IV over
15 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
Previously collected tumor blocks are assessed for cancer resistance markers by IHC.
After completion of study treatment, patients are followed for 1 month, and then every 3
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria
The interim analysis will study the objective response to treatment in the first cohort of 29 patients. Response will be assessed according to NCI -Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
Ongoing throughout trial
John Crown, MD
St. Vincent's University Hospital
Ieland: Irish Medicines Board