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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00538005
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma
* Metastatic disease
* Measurable or evaluable non-CNS disease
* Measurable disease, defined as a unidimensionally measurable lesion as determined by physical exam, x-ray, CT scan, MRI, or other radiographic procedure
* Evaluable disease, defined as a lesion that can be seen radiographically but is not unidimensionally measurable
* Previously irradiated lesions with documented progression are allowed provided there are no other sites of metastatic disease
* No active brain metastases
* Previously treated, responding brain metastases allowed, provided there is measurable disease outside of the CNS
* At least 3 weeks since prior chemotherapy and 6 weeks since prior radiotherapy for CNS disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* ANC ≥ 1,200/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
* Bilirubin ≤ 3.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* EKG with no evidence of serious arrhythmia or recent myocardial infarction
Exclusion criteria:
* Active infection
* Chronic underlying immunodeficiency disease
* Other serious concurrent illness
* Other forms of cancer within 5 years of initial diagnosis except nonmelanoma skin cancer and cervical cancer
* Congestive heart failure or myocardial infarction within the past 6 months
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* See Disease Characteristics
* At least 6 weeks since prior radiotherapy
* More than 4 weeks since prior surgery
* Prior biologic therapy allowed
Exclusion criteria:
* Prior cytotoxic agents
* Prior sorafenib tosylate, bevacizumab, or oxaliplatin
* Concurrent biological therapy, except growth factors for anemia, neutropenia, or thrombocytopenia
* Concurrent radiotherapy, chemotherapy, or surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00538005
Study Brief:
Protocol Section:
NCT00538005