Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma
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.
Drug: epirubicin hydrochloride
Other: immunologic technique
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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 this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria [ Time Frame: Ongoing throughout trial ] [ Designated as safety issue: No ]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
- Toxicity according to NCI CTCAE v.3.0 [ Time Frame: Ongoing throughout trial ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
|Experimental: Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg||Drug: epirubicin hydrochloride Drug: sulindac Other: immunologic technique|
- 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 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755976
|Cork University Hospital|
|Dublin, Ireland, 9|
|Mater Misericordiae University Hospital|
|Dublin, Ireland, 7|
|National Institute for Cellular Biotechnology at Dublin City University|
|Dublin, Ireland, 9|
|St. James's Hospital|
|Dublin, Ireland, 8|
|St. Vincent's University Hospital|
|Dublin, Ireland, 4|
|Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital|
|Dublin, Ireland, 24|
|Galway University Hospital|
|Mid-Western Cancer Centre at Mid-Western Regional Hospital|
|Limerick, Ireland, 0009|
|Waterford Regional Hospital|
|Principal Investigator:||John Crown, MD||St. Vincent's University Hospital|