RATIONALE: Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sulindac together with epirubicin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving sulindac together with epirubicin works in treating patients with metastatic malignant melanoma.
OBJECTIVES: Primary * To estimate the non-comparative efficacy of sulindac and epirubicin hydrochloride in patients with metastatic malignant melanoma. Secondary * 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 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Cork University Hospital
Cork, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland
St. Vincent's University Hospital
Dublin, Ireland
Mater Misericordiae University Hospital
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
Time frame: Ongoing throughout trial
Toxicity according to NCI CTCAE v.3.0
Time frame: Ongoing throughout trial
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Dublin, Ireland
St. James's Hospital
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland
National Institute for Cellular Biotechnology at Dublin City University
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Mid-Western Cancer Centre at Mid-Western Regional Hospital
Limerick, Ireland
Waterford Regional Hospital
Waterford, Ireland