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Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced 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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
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
Start Date
August 1, 2007
Primary Completion Date
May 1, 2010
Completion Date
May 1, 2010
Last Updated
December 31, 2014
32
ACTUAL participants
epirubicin hydrochloride
DRUG
sulindac
DRUG
immunologic technique
OTHER
Lead Sponsor
Cancer Trials Ireland
NCT04079166
NCT04911998
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This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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