Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00755976
First received: September 13, 2008
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Melanoma (Skin)
Drug: epirubicin hydrochloride
Drug: sulindac
Other: immunologic technique
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Toxicity according to NCI CTCAE v.3.0 [ Time Frame: Ongoing throughout trial ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: August 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg Drug: epirubicin hydrochloride Drug: sulindac Other: immunologic technique

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755976

Locations
Ireland
Cork University Hospital
Cork, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24
Beaumont Hospital
Dublin, Ireland, 9
Mater Misericordiae University Hospital
Dublin, Ireland, 7
St. James's Hospital
Dublin, Ireland, 8
St. Vincent's University Hospital
Dublin, Ireland, 4
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
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: John Crown, MD St. Vincent's University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT00755976     History of Changes
Obsolete Identifiers: NCT00632177
Other Study ID Numbers: CDR0000613992, ICORG-06-03, EUDRACT-2006-006051-12, EU-20876
Study First Received: September 13, 2008
Last Updated: October 18, 2012
Health Authority: Ieland: Irish Medicines Board

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
stage IV melanoma

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

ClinicalTrials.gov processed this record on July 26, 2014