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:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT00268450
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed transitional cell cancer (TCC) of the bladder
* Staged as follows:
* Muscle invasive (T2-T4a)
* Node negative (N0)
* No histologically or cytologically proven lymph node metastases
* Nonmetastatic (M0)
* No evidence of distant metastases
* Resectable disease
* Able to begin protocol treatment within 6 weeks after transurethral resection and cystoscopic evaluation
* No central nervous system or brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status of 0-2
* Karnofsky 60-100%
* White blood cell count ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* AST(SGOT) and ALT(SGPT) ≤ 2 times upper limit of normal
* Bilirubin ≤1.5 mg/dL
* Creatinine clearance ≥ 60 mL/min
* Urine protein/creatinine ratio \< 1.0
* Blood pressure ≤150/100 mm Hg
* No prohibitive medical risks for chemotherapy
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, gemcitabine hydrochloride, or paclitaxel
* No unstable angina
* No history of myocardial infarction within the past 6 months
* No cardiac arrhythmias
* No New York Heart Association (NYHA) congestive heart failure ≥ grade 2
* No history of stroke within the past 6 months
* No clinically significant peripheral vascular disease
* No evidence of bleeding diathesis or coagulopathy
* No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No serious nonhealing wound, ulcer, or bone fracture
* No psychiatric illness or other psychosocial situation that would limit ability to comply with study and/or follow-up procedures
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must agree to use adequate contraception prior to study entry and for the duration of study participation
* No significant traumatic injury with in the past 28 days
PRIOR CONCURRENT THERAPY:
* No prior systemic chemotherapy
* No prior pelvic radiation therapy
* More than 4 weeks since prior participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
* No concurrent participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
* No major surgical procedure or open biopsy within the past 28 days
* No anticipation of need for major surgical procedure during the course of the study
* No minor surgical procedures, fine-needle aspirations, or core biopsies within the past 7 days
* No concurrent treatment with hormones or other chemotherapeutic agents except the following:
* Steroids given for adrenal failure
* Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
* Intermittent use of dexamethasone as an antiemetic in solid tumor protocols
* No other concurrent investigational or commercial agents or therapies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00268450
Study Brief:
Protocol Section:
NCT00268450