Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma
- Conditions
- Melanoma (Skin)
- Interventions
- Registration Number
- NCT00755976
- Lead Sponsor
- Cancer Trials Ireland
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg epirubicin hydrochloride - Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg immunologic technique - Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg sulindac -
- Primary Outcome Measures
Name Time Method To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria Ongoing throughout trial 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
- Secondary Outcome Measures
Name Time Method Toxicity according to NCI CTCAE v.3.0 Ongoing throughout trial
Trial Locations
- Locations (10)
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
🇮🇪Dublin, Ireland
Cork University Hospital
🇮🇪Cork, Ireland
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Beaumont Hospital
🇮🇪Dublin, Ireland
Waterford Regional Hospital
🇮🇪Waterford, Ireland
St. James's Hospital
🇮🇪Dublin, Ireland
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
National Institute for Cellular Biotechnology at Dublin City University
🇮🇪Dublin, Ireland
Mid-Western Cancer Centre at Mid-Western Regional Hospital
🇮🇪Limerick, Ireland
Galway University Hospital
🇮🇪Galway, Ireland