Melanoma Epirubicin Sulindac Trial: Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
Information source: All Ireland Cooperative Oncology Research Group
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Melanoma
Intervention: Epirubicin and Sulindac (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: All Ireland Cooperative Oncology Research Group Overall contact:
John Crown, Prof, Phone: +353-1-2094895, Email: john.crown@icorg.ie
Summary
Advanced melanoma responds very poorly to chemotherapy treatment. Drug resistance is a common
phenomenon, including MRP-1 (multi-drug resistance protein) expression. Sulindac is an MRP-1
inhibitor with other therapeutic properties. Epirubicin has a very limited efficacy in
melanoma. A strong response was seen in patients with advanced melanoma in the phase I
trial.
Clinical Details
Official title: Phase II Trial of the Multi-Drug Resistance Protein Modulating Agent Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: RECIST guidelines
Detailed description:
Advanced melanoma responds very poorly to chemotherapy treatment. Drug resistance is a common
phenomenon, including MRP-1 (multi-drug resistance protein) expression. Sulindac is an MRP-1
inhibitor with other therapeutic properties. Epirubicin has a very limited efficacy in
melanoma. A strong response was seen in a patients with advanced melanoma in the phase I
trial.
Treatment Plan: 6 cycles, 21 days apart. Sulindac administered as 3x 200mg tablets orally and
two hours later: 75mg/m2 epirubicin by standard 15 minute infusion. Standard dexamethasone
regime plus anti-emetics.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must have a histologically documented malignant melanoma which is metastatic,
and their tumor block should be available for resistance marker analysis.
- Patients must have either measurable or evaluable disease.
- Patients must have a Karnofsky Performance Status of > 70%.
- Patients must have a normal cardiac ejection fraction, normal cardiac wall motion and
ECG.
- Patients must have the following hematological parameters: absolute neutrophil count:
> 1. 0 x 10^9/L, platelet count > 100 x 10^9/L, hemoglobin > 9 g/dl.
- Patients must have normal serum bilirubin except patients with benign congenital
hyperbilirubinaemia.
- Patients must have signed informed consent indicating full understanding of the risks
and potential benefits of the research as outlined in the information sheet.
- Patients must be older than 18 years of age.
Exclusion Criteria:
- Patients must not have active heart disease, including a history of myocardial
infarction within one year, pericarditis or existing hypertension requiring
treatment.
- Patients must not have had a prior anthracycline, anthracenedione-containing
chemotherapy regime, or cardiac radiotherapy.
- Patients with active brain metastases are ineligible. Patients who have had successful
complete excision of solitary brain metastasis are not excluded.
- Patients must not be pregnant or lactating. Pre-menopausal women must have a negative
pregnancy test.
- Patients must not have had major surgery within the previous 2 weeks.
- Patients must not have participated in any clinical trial within the previous four
weeks.
- Patients must not be treated with any other anti-cancer therapies during the study
period, with the exception of patients who are on bisphosphonate therapy for bony
metastases. Such patients must have extra-osseous measurable/evaluable lesions
- Patients must not receive any other experimental medications during the study period.
- Patients must not have any other active serious medical or psychiatric disease.
- Patients must not have had a prior or concomitant malignancy, other than basal cell
carcinoma of the skin or in-situ neoplasia of the cervix uteri.
Locations and Contacts
John Crown, Prof, Phone: +353-1-2094895, Email: john.crown@icorg.ie
University College Hospital Galway, Galway, Ireland; Recruiting
Dr Maccon Keane, Phone: 35-39-154-4141
Mater Hospitals, Eccles Street, D 7, Ireland; Recruiting
Dr John McCaffrey, Phone: 35-31-803-4834
St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland; Recruiting
Prof. John Crown, Phone: 35-31-209-4982
St. James's Hospital, James's Street, Dublin 8, Ireland; Recruiting
Dr John Kennedy, Phone: 35-31-410-3754
Beaumont Hospital, Beaumont Road, Dublin 9, Ireland; Recruiting
Dr Oscar Breathnach, Phone: 35-31-809-2082
AMNCH, Tallaght, Dublin 24, Ireland; Recruiting
Dr Ray McDermott, Phone: 35-31-414-2892
Mid Western Regional Hospital, Dooradoyle, Limerick, Ireland; Recruiting
Prof. Rajnish Gupta, Phone: 35-36-148-5148
Waterford Regional Hospital, Dunmore Road, Waterford, Ireland; Recruiting
Dr Paula Calvert, Phone: 35-35-184-8861
Additional Information
Starting date: May 2007
Last updated: June 25, 2008
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