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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT00006105
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Completely resected locally advanced bladder cancer
* T2-4, N0-2
* Post radical cystectomy with no gross residual disease
* No evidence of metastases by CT of chest, abdomen, and pelvis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL (transfusion allowed)
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST and ALT no greater than 3 times ULN
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 50 mL/min
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after study participation
* No active infection
* No serious concurrent systemic disorders that would preclude study participation
* No metastatic cancer in past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
Chemotherapy:
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except contraceptives and replacement steroids
Radiotherapy:
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 4 but no more than 8 weeks since radical cystectomy
Other:
* No other concurrent experimental medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006105
Study Brief:
Protocol Section:
NCT00006105