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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT00006351
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic or unresectable primary transitional cell carcinoma of the urinary tract, including bladder, ureter, and renal pelvis
* At least one measurable lesion
* 20 mm or greater by conventional techniques OR
* 10 mm or greater by spiral CT scan
* Must have received one (and only one) prior chemotherapy regimen for advanced or metastatic disease
* No clinical signs of brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Absolute neutrophil count at least 2,000/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN with liver metastases)
Renal:
* Creatinine no greater than 1.7 mg/dL
Cardiovascular:
* Normal cardiac function
* No ischemic heart disease within the past 6 months
* Normal 12 lead ECG
Other:
* No prior gastrectomy or any gastrointestinal disease that may impair absorption of SCH 66336
* No unstable systemic disease
* No active uncontrolled infection
* No psychological, familial, sociological, or geographical condition that would preclude study
* No prior or concurrent other malignancy except cone biopsied carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* No prior farnesyl protein transferase inhibitors or gemcitabine
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* At least 2 weeks since prior major surgery
Other:
* No other concurrent anticancer agents
* No other concurrent investigational therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006351
Study Brief:
Protocol Section:
NCT00006351