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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00003105
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed transitional cell carcinoma of the urothelium
* Measurable disease, defined as unresectable or metastatic urothelial tract tumors OR
* Evaluable disease, defined as T3b or T4a bladder tumors
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count greater than 1,500/mm\^3
* Platelet count greater than 150,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times normal
* SGOT less than 2 times normal
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No New York Heart Association class III or IV heart disease
* No serious cardiac arrhythmias, including first, second, or third degree heart block
* LVEF at least 50%
Other:
* No uncontrolled infection
* No other active malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
* Fertile patients must use effective barrier contraception before, during, and for 6 months after study and are encouraged to continue for 2 years or longer after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior systemic chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 3 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003105
Study Brief:
Protocol Section:
NCT00003105