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Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00755976
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : December 31, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Drug: epirubicin hydrochloride Drug: sulindac Other: immunologic technique Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2007
Primary Completion Date : May 2010
Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg Drug: epirubicin hydrochloride Drug: sulindac Other: immunologic technique

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Toxicity according to NCI CTCAE v.3.0 [ Time Frame: Ongoing throughout trial ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant melanoma

    • Metastatic disease
  • Tumor block available for resistance marker analysis
  • Measurable or evaluable disease
  • No active brain metastases except for patients who have undergone successful complete excision of solitary brain metastasis


  • Karnofsky performance status 80-100%
  • ANC > 1 x 10^9/L
  • Platelet count > 100 x 10^9/L
  • Hemoglobin > 9 g/dL
  • Serum bilirubin normal (except in patients with benign congenital hyperbilirubinemia)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Normal cardiac ejection fraction, cardiac wall motion, and ECG
  • No active heart disease, including any of the following:

    • Myocardial infarction within the past year
    • Pericarditis
    • Existing hypertension requiring treatment
  • No other active serious medical or psychiatric disease
  • No prior or concurrent malignancy, other than basal cell carcinoma of the skin , or carcinoma in-situ of the cervix


  • No prior anthracycline or anthracenedione-containing chemotherapy regimen
  • No prior cardiac radiotherapy
  • No major surgery within the past 2 weeks
  • No participation in any clinical trial within the past 4 weeks
  • No other concurrent anticancer therapies

    • Concurrent bisphosphonates allowed in patients with bony metastases with extra-osseous measurable or evaluable lesions
  • No other concurrent experimental medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755976

Cork University Hospital
Cork, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24
St. Vincent's University Hospital
Dublin, Ireland, 4
Mater Misericordiae University Hospital
Dublin, Ireland, 7
St. James's Hospital
Dublin, Ireland, 8
Beaumont Hospital
Dublin, Ireland, 9
National Institute for Cellular Biotechnology at Dublin City University
Dublin, Ireland, 9
Galway University Hospital
Galway, Ireland
Mid-Western Cancer Centre at Mid-Western Regional Hospital
Limerick, Ireland, 0009
Waterford Regional Hospital
Waterford, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
Principal Investigator: John Crown, MD St. Vincent's University Hospital

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT00755976     History of Changes
Obsolete Identifiers: NCT00632177
Other Study ID Numbers: 06-03 ICORG
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: October 2012

Keywords provided by Cancer Trials Ireland:
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors