Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 32
- Locations
- 10
- Primary Endpoint
- To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg
Intervention: epirubicin hydrochloride (Drug)
Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg
Intervention: sulindac (Drug)
Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg
Intervention: immunologic technique (Other)
Outcomes
Primary Outcomes
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
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 Outcomes
- Toxicity according to NCI CTCAE v.3.0(Ongoing throughout trial)