Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT00017316
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic melanoma
* Bidimensionally measurable disease by MRI, CT scan, or chest x-ray
* No active brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* More than 12 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 8.5 g/dL
Hepatic:
* PT/PTT normal
* Bilirubin no greater than 1.5 mg/dL
* SGOT/SGPT no greater than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No uncompensated coronary artery disease by electrocardiogram or physical exam
* No myocardial infarction or severe or unstable angina within the past 6 months
* No deep venous thrombosis within the past 3 months
* No arterial thrombosis within the past 6 months
Pulmonary:
* No pulmonary embolism within the past 6 months
Other:
* HIV negative
* No active infection
* No medical, psychological, or social problem that would preclude study participation
* No history of gastrointestinal disorder that would interfere with absorption or swallowing of study medication
* No emotional disorder or substance abuse
* No diabetes mellitus with severe peripheral vascular disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 1 prior biologic regimen
* No concurrent biologic response modifiers
* No concurrent hematopoietic growth factor support
* Concurrent epoetin alfa allowed
Chemotherapy:
* No concurrent cytotoxic agents
Endocrine therapy:
* No concurrent anticancer hormonal therapy except megestrol acetate for appetite stimulation
Radiotherapy:
* No prior large field radiotherapy to more than 20% total bone marrow
* No concurrent radiotherapy
Surgery:
* At least 14 days since major surgery
* No prior major upper gastrointestinal surgery
Other:
* No other concurrent investigational therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00017316
Study Brief:
Protocol Section:
NCT00017316