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:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT00568451
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic melanoma
* Stage IV disease
* Progressive disease
* No known standard therapy that is potentially curative or proven capable of extending life expectancy exists
* Planning to undergo chemotherapy with paclitaxel and carboplatin OR temozolomide alone for progressive disease
* Measurable disease as defined by RECIST criteria
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* ANC ≥ 1,500/mL
* Platelet count ≥ 100,000/mL
* Hemoglobin ≥ 9 g/dL
* Creatinine ≤ 2.5 x upper limit of normal (ULN)
* AST ≤ 3 x ULN
* Alkaline phosphatase ≤ 3.0 x ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after completion of study therapy
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Active infection
* NYHA class III or IV congestive heart failure
* No history of other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
* Willing to provide research blood samples
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* At least 4 weeks since prior radiotherapy
* At least 4 weeks since prior chemotherapy (patients who received chemotherapy in the metastatic setting)
* No prior chemotherapy treatment with agents similar to study drugs
* No prior chemotherapy in the metastatic setting (for chemo-naive patients)
* No concurrent enrollment in a different clinical study in which investigational procedures or agents are being used
* No other concurrent investigational agents
* No other concurrent chemotherapy or radiotherapy, including palliative radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00568451
Study Brief:
Protocol Section:
NCT00568451