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:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT00492505
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Confirmed diagnosis of melanoma
* High-risk, stage III disease
* No measurable metastatic disease
* Has undergone surgery within the past 8 weeks
* Surgically rendered disease free
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Creatinine clearance ≥ 50 mL/min OR creatinine ≤ 1.5 mg/dL
* Liver function tests ≤ 3 times the upper limit of normal
* ANC ≥ 1,200/mm³
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm³
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No myocardial infarction within the past 6 months
* No congestive heart failure requiring medication
* No pulmonary disease requiring supplemental oxygen
* No dyspnea at rest
* No active infection
* No chronic underlying immunodeficiency disease
* No other serious illness that, in the physicians' opinion, may compromise the safety of the patient
* No other cancer within the past 5 years except for nonmelanoma skin cancer and cervical cancer
* No thromboembolic disease within the past 6 months
PRIOR CONCURRENT THERAPY:
* No prior tamoxifen citrate, sorafenib tosylate, or cisplatin
* No concurrent radiotherapy or surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00492505
Study Brief:
Protocol Section:
NCT00492505