Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

December 30, 2014 updated by: Cancer Trials Ireland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Cork University Hospital
      • Dublin, Ireland, 9
        • Beaumont Hospital
      • Dublin, Ireland, 7
        • Mater Misericordiae University Hospital
      • Dublin, Ireland, 4
        • St. Vincent'S University Hospital
      • Dublin, Ireland, 24
        • Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
      • Dublin, Ireland, 8
        • St. James's Hospital
      • Dublin, Ireland, 9
        • National Institute for Cellular Biotechnology at Dublin City University
      • Galway, Ireland
        • Galway University Hospital
      • Limerick, Ireland, 0009
        • Mid-Western Cancer Centre at Mid-Western Regional Hospital
      • Waterford, Ireland
        • Waterford Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg
Drug: epirubicin hydrochloride
Other: immunologic technique
Drug: sulindac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria
Time Frame: Ongoing throughout trial
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 Outcome Measures

Outcome Measure
Time Frame
Toxicity according to NCI CTCAE v.3.0
Time Frame: Ongoing throughout trial
Ongoing throughout trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

September 13, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (ESTIMATE)

September 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-03 ICORG
  • ICORG-06-03
  • EUDRACT-2006-006051-12
  • EU-20876

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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