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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00028860
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of transitional cell carcinoma of the urothelium including bladder, ureter, and renal pelvis
* T3b-4, N0, M0 OR
* Any T, N1-3, M0
* Cystectomy within the past 8 weeks
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* ECOG 0-1
Life expectancy:
* At least 12 months
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST or ALT no greater than 2.5 times ULN
Renal:
* Creatinine no greater than ULN
* Albumin no greater than ULN
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior malignancy except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer
* No active serious infection, other serious underlying medical condition, dementia, or significantly altered mental status that would preclude study participation
* No known hypersensitivity to Cremophor EL
* No pre-existing clinically significant grade 2 or greater neuropathy
* No AIDS (HIV positivity alone allowed)
* No known hypersensitivity to E. coli-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for malignancy
* No neoadjuvant chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for malignancy
Surgery:
* See Disease Characteristics
Other:
* No other concurrent investigational therapy
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00028860
Study Brief:
Protocol Section:
NCT00028860