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Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
Ireland
Study Type
Interventional
Intervention
epirubicin hydrochloride
sulindac
immunologic technique
Sponsored by
Cancer Trials Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity according to NCI CTCAE v.3.0

Full Information

First Posted
September 13, 2008
Last Updated
December 30, 2014
Sponsor
Cancer Trials Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT00755976
Brief Title
Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma
Official Title
Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Trials Ireland

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
sulindac
Intervention Type
Other
Intervention Name(s)
immunologic technique
Primary Outcome Measure Information:
Title
To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria
Description
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
Time Frame
Ongoing throughout trial
Secondary Outcome Measure Information:
Title
Toxicity according to NCI CTCAE v.3.0
Time Frame
Ongoing throughout trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Crown, MD
Organizational Affiliation
St. Vincent's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
St. James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
National Institute for Cellular Biotechnology at Dublin City University
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Galway University Hospital
City
Galway
Country
Ireland
Facility Name
Mid-Western Cancer Centre at Mid-Western Regional Hospital
City
Limerick
ZIP/Postal Code
0009
Country
Ireland
Facility Name
Waterford Regional Hospital
City
Waterford
Country
Ireland

12. IPD Sharing Statement

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Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

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