Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

NCT00755976 | Completed Phase 2

• 4 other identifiers: 06-03 ICORGICORG-06-03EUDRACT-2006-006051-12EU-20876
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 10

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria

  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

  Ongoing throughout trial

Secondary Outcomes (1)

• Toxicity according to NCI CTCAE v.3.0

  Ongoing throughout trial

Study Arms (1)

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

EXPERIMENTAL

Drug: epirubicin hydrochloride; Drug: sulindac; Other: immunologic technique

Interventions

epirubicin hydrochloride DRUG

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

sulindac DRUG

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

immunologic technique OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (10)

Cork University Hospital

Cork, Ireland

Location

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

Dublin, 24, Ireland

Location

St. Vincent's University Hospital

Dublin, 4, Ireland

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

St. James's Hospital

Dublin, 8, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

National Institute for Cellular Biotechnology at Dublin City University

Dublin, 9, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Mid-Western Cancer Centre at Mid-Western Regional Hospital

Limerick, 0009, Ireland

Location

Waterford Regional Hospital

Waterford, Ireland

Location

MeSH Terms

Conditions

Melanoma

Interventions

Epirubicin; Sulindac; Immunologic Techniques

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Indenes; Investigative Techniques

Study Officials

• John Crown, MD

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2008
• First Posted: September 19, 2008
• Study Start: August 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 31, 2014

Record last verified: 2012-10

Locations

IE (10)