Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

NCT ID: NCT00755976

Last Updated: 2014-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-05-31

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.

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg

Group Type: EXPERIMENTAL

epirubicin hydrochloride

Intervention Type: DRUG

sulindac

Intervention Type: DRUG

immunologic technique

Intervention Type: OTHER

Interventions

epirubicin hydrochloride

Intervention Type: DRUG

sulindac

Intervention Type: DRUG

immunologic technique

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Trials Ireland

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Crown, MD

Role: PRINCIPAL_INVESTIGATOR

St Vincent's University Hospital

Locations

Cork University Hospital

Cork, , Ireland

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

Dublin, , Ireland

St. Vincent's University Hospital

Dublin, , Ireland

Mater Misericordiae University Hospital

Dublin, , Ireland

St. James's Hospital

Dublin, , Ireland

Beaumont Hospital

Dublin, , Ireland

National Institute for Cellular Biotechnology at Dublin City University

Dublin, , Ireland

Galway University Hospital

Galway, , Ireland

Mid-Western Cancer Centre at Mid-Western Regional Hospital

Limerick, , Ireland

Waterford Regional Hospital

Waterford, , Ireland

Countries

Ireland

Other Identifiers

ICORG-06-03

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2006-006051-12

Identifier Type: -

Identifier Source: secondary_id

EU-20876

Identifier Type: -

Identifier Source: secondary_id

06-03 ICORG

Identifier Type: -

Identifier Source: org_study_id

NCT00632177

Identifier Type: -

Identifier Source: nct_alias