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

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

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Trial Information

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



- To estimate the non-comparative efficacy of sulindac and epirubicin hydrochloride in
patients with metastatic malignant melanoma.


- 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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

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

Outcome Measure:

To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria

Outcome 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

Outcome Time Frame:

Ongoing throughout trial

Safety Issue:


Principal Investigator

John Crown, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Vincent's University Hospital


Ieland: Irish Medicines Board

Study ID:




Start Date:

August 2007

Completion Date:

May 2010

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • Melanoma