Status:
COMPLETED
Sulindac and Epirubicin in Treating Patients With Metastatic Malignant Melanoma
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00755976
Start Date
August 1 2007
End Date
May 1 2010
Last Update
December 31 2014
Active Locations (10)
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1
Cork University Hospital
Cork, Ireland
2
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24
3
St. Vincent's University Hospital
Dublin, Ireland, 4
4
Mater Misericordiae University Hospital
Dublin, Ireland, 7