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Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00755976
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Tracking Information
First Submitted Date  ICMJE September 13, 2008
First Posted Date  ICMJE September 19, 2008
Last Update Posted Date December 31, 2014
Study Start Date  ICMJE August 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2008)
Non-comparative efficacy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2012)
Toxicity according to NCI CTCAE v.3.0 [ Time Frame: Ongoing throughout trial ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2008)
Toxicity according to NCI CTCAE v.3.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma
Official Title  ICMJE Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE
  • Drug: epirubicin hydrochloride
  • Drug: sulindac
  • Other: immunologic technique
Study Arms  ICMJE Experimental: Epirubicin hydrochloride (75mg/m2 i.v.) Sulindac: 600mg
Interventions:
  • Drug: epirubicin hydrochloride
  • Drug: sulindac
  • Other: immunologic technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2012)
32
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2008)
38
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00755976
Other Study ID Numbers  ICMJE 06-03 ICORG
ICORG-06-03
EUDRACT-2006-006051-12
EU-20876
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cancer Trials Ireland
Study Sponsor  ICMJE Cancer Trials Ireland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Crown, MD St. Vincent's University Hospital
PRS Account Cancer Trials Ireland
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP