Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma

Cancer Trials Ireland

Status and phase

Completed

Phase 2

Conditions

Melanoma (Skin)

Treatments

Drug: epirubicin hydrochloride

Drug: sulindac

Other: immunologic technique

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00755976

06-03 ICORG

EUDRACT-2006-006051-12

EU-20876

ICORG-06-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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