Melanoma (Skin)
Conditions
Keywords
stage IV 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.
Interventions
Sponsors
Cancer Trials Ireland
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To estimate the non-comparative efficacy of this treatment combination in patients with malignant melanoma. Response will be assessed using the RECIST Criteria | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity according to NCI CTCAE v.3.0 | Ongoing throughout trial |
Countries
Ireland
Outcome results
None listed