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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT00022633
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed urothelial cancer
* Transitional cell carcinoma, adenocarcinoma, or squamous carcinoma (bladder, renal pelvis, ureter, or urethra)
* Previously untreated metastatic or locoregionally advanced (i.e., bulky pelvic nodes) disease OR
* Locally recurrent carcinoma after radiotherapy or cystectomy and no longer eligible for further radiotherapy or surgery
* Measurable disease
PATIENT CHARACTERISTICS:
Age:
* 70 and over OR
* Under 60
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,200/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* Aspartate aminotransferase (SGOT) or alanine aminotransferase (SGPT) no greater than 2 times ULN
Renal:
* Creatinine no greater than ULN
Other:
* HIV negative
* No other concurrent life-threatening medical disorder that would preclude study participation
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior adjuvant chemotherapy is allowed provided administered more than 10 years ago
* No prior gemcitabine, taxanes, or platinum-based adjuvant chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 28 days since prior radiotherapy and recovered
Surgery:
* See Disease Characteristics
* At least 28 days since prior surgery and recovered
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
120 Years
Study:
NCT00022633
Study Brief:
Protocol Section:
NCT00022633