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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00066612
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, renal pelvis, ureter, and urethra
* Stage T2-4, N0-3, M1 OR stage T2-4, N+, M0, unresectable disease
* The following additional histologic subtypes are eligible:
* Poorly differentiated TCC
* Predominant TCC with rare foci of squamous differentiation
* Predominant TCC with rare foci of adenocarcinoma
* The following histologic subtypes are ineligible:
* Adenocarcinoma
* Small cell carcinoma
* Sarcoma
* Squamous cell carcinoma
* Mixed adeno/squamous/transitional histology
* Incurable by surgery or radiotherapy
* Progressed or recurred after 1, and only 1, prior cisplatin- or carboplatin-containing systemic regimen for metastatic disease
* Measurable disease
* Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
* No uncontrolled central nervous system (CNS) metastases
* CNS metastases that have responded to or stabilized after prior radiotherapy are allowed
PATIENT CHARACTERISTICS:
Age
* 18 and over
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 less than 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (SGOT) less than 3 times ULN (5 times ULN if liver metastases are present)
Renal
* Creatinine less than 2 times ULN
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other 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 that is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 28 days since prior chemotherapy
* No prior topoisomerase I inhibitors (e.g., irinotecan or topotecan)
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 28 days since prior radiotherapy to the pelvis
Surgery
* Not specified
Other
* Recovered from prior therapy
* Prior adjuvant therapy allowed
* At least 14 days since prior Hypericum perforatum (St. John's Wort)
* More than 7 days since prior phenytoin, phenobarbital, carbamazepine, or any other enzyme-inducing anticonvulsant drugs (EIACDs)
* No St. John's Wort during and for 7 days after study participation
* No concurrent EIACDs
* No concurrent medications that cause myelosuppression
* No concurrent medications that cause diarrhea
* Concurrent gabapentin or other non-EIACDs are allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00066612
Study Brief:
Protocol Section:
NCT00066612