Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

Melanoma (Skin) Clinical Trial

Official title:

Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755976
• Other study ID #: 06-03 ICORG
• Secondary ID: ICORG-06-03EUDRA
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2008
• Last updated: December 30, 2014
• Start date: August 2007
• Est. completion date: May 2010

Study information

• Verified date: October 2012
• Source: ICORG- All Ireland Cooperative Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ieland: Irish Medicines Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00632177

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• epirubicin hydrochloride

• sulindac

Other:
• immunologic technique

Locations

Country	Name	City	State
Ireland	Cork University Hospital	Cork
Ireland	Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital	Dublin
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	National Institute for Cellular Biotechnology at Dublin City University	Dublin
Ireland	St. James's Hospital	Dublin
Ireland	St. Vincent's University Hospital	Dublin
Ireland	Galway University Hospital	Galway
Ireland	Mid-Western Cancer Centre at Mid-Western Regional Hospital	Limerick
Ireland	Waterford Regional Hospital	Waterford

Sponsors (1)

Lead Sponsor	Collaborator
ICORG- All Ireland Cooperative Oncology Research Group

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Toxicity according to NCI CTCAE v.3.0		Ongoing throughout trial	Yes