Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Biomarker/Laboratory analysis, Treatment Active Over 18 Other ICORG-06-03 ICORG 06-03 Epi Sulindac, EUDRACT-2006-006051-12, EU-20876, NCT00755976

Objectives

Primary

1. To estimate the non-comparative efficacy of sulindac and epirubicin hydrochloride in patients with metastatic malignant melanoma.

Secondary

1. To characterize the toxicity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

• Karnofsky performance status 80-100%
• ANC > 1 x 10⁹/L
• Platelet count > 100 x 10⁹/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

Expected Enrollment

Outcomes

Non-comparative efficacy

Toxicity according to NCI CTCAE v.3.0

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.

Trial Contact Information

Trial Lead Organizations

Irish Clinical Oncology Research Group

John Crown, MD, Principal investigator		Ph: 353-1-209-4895 Email: john.crown@icorg.ie

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

Registry Information
Official Title		Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
Trial Start Date		2007-08-01
Trial Completion Date		2009-08-31 (estimated)
Registered in ClinicalTrials.gov		NCT00755976
Date Submitted to PDQ		2008-08-29
Information Last Verified		2008-09-23