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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT00006003
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed melanoma with documented metastatic disease
* In transit metastases allowed
* Lesion accessible for biopsy
* Measurable disease
* Greater than 20 mm by conventional techniques ORgreater than 10 mm by spiral CT
* Documented progressive disease by radiologic study or physical examination
* Known history of CNS metastasis who have had treatment, are neurologicallystable, and do not require intravenous antibiotics or anticonvulsants eligibleprovided oral steroids are not required and brain scan (CT or MRI) showsabsence of active or residual disease
* If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required
* Performance status - WHO 0-2
* At least 12 weeks
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No uncompensated coronary artery disease
* No history of myocardial infarction or severe/unstable angina within past 6 months
* No severe peripheral vascular disease associated with diabetes mellitus
* No deep venous or arterial thrombosis within past 3 months
* No pulmonary embolism within past 3 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other significant uncontrolled underlying medical or psychiatric illness
* No serious active infections
* No other malignancy within past 5 years except for curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel
* No other concurrent chemotherapy
* No other concurrent investigational antineoplastic drugs
* See Disease Characteristics
* No prior radiotherapy to only site of measurable disease
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
* No greater than 1 prior therapy for metastatic disease
* At least 4 weeks since prior therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006003
Study Brief:
Protocol Section:
NCT00006003