Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma - Full Text View

Sponsor:	Irish Clinical Oncology Research Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00755976

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
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:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Sulindac Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Non-comparative efficacy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity according to NCI CTCAE v.3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment:	38
Study Start Date:	August 2007
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

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

Locations

Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital	Recruiting
Dublin, Ireland, 24
Contact: Ray McDermott, MD 353-1-414-2012 ray.mcdermott@amnch.ie
Beaumont Hospital	Recruiting
Dublin, Ireland, 9
Contact: Oscar Breathnach, MD 353-1-809-2373
Cork University Hospital	Recruiting
Cork, Ireland
Contact: Seamus O'Reilly, MD, BSc, PhD 353-21-454-6400
Galway University Hospital	Recruiting
Galway, Ireland
Contact: Maccon M. Keane, MD 353-91-544-805 maccon.keane@mailn.hse.ie
Mater Misericordiae University Hospital	Recruiting
Dublin, Ireland, 7
Contact: John McCaffrey, MD 353-1-885-8569
Waterford Regional Hospital	Recruiting
Waterford, Ireland
Contact: Paula M. Calvert, MD 353-51-842-595
National Institute for Cellular Biotechnology at Dublin City University	Recruiting
Dublin, Ireland, 9
Contact: Robert O'Connor, MD 353-1-700-5700 robert.oconnor@dcu.ie
St. James's Hospital	Recruiting
Dublin, Ireland, 8
Contact: M. John Kennedy, MD 353-1-416-2169 jkennedy@stjames.ie
St. Vincent's University Hospital	Recruiting
Dublin, Ireland, 4
Contact: John Crown, MD 353-1-209-4895
Mid-Western Cancer Centre at Mid-Western Regional Hospital	Recruiting
Limerick, Ireland, 0009
Contact: Rajnish K. Gupta, MD 353-61-482-542

Sponsors and Collaborators

Irish Clinical Oncology Research Group

Investigators

Principal Investigator:

John Crown, MD

St. Vincent's University Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000613992, ICORG-06-03, EUDRACT-2006-006051-12, EU-20876
Study First Received:	September 13, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00755976 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Melanoma
Sensory System Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Neoplasms by Histologic Type
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Epirubicin
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Analgesics, Non-Narcotic
Sulindac
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009