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 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT00478361
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder, urethra, or upper urinary tract
* Mixed TCC and variant histologies (i.e., small cell, squamous cell, adenocarcinoma, or sarcoma) allowed if present in \< 50% of the biopsy specimen
* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
* Measurable disease: may include radiographic detection of metastases in lymph nodes (\>= 1.5 cm) or liver or lung (\>= 1.0 cm) OR pelvic mass palpable on examination under anesthesia
* Creatinine clearance \< 60 mL/min; no renal insufficiency that requires hemodialysis; no renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy)
* Zubrod performance status 0-2
* Platelet count \> 100,000/mm\^3
* Absolute granulocyte count \> 1,500/mm\^3
* Bilirubin =\< 2.0 mg/dL
* Aminotransferases (AST and ALT) =\< 2 times upper limit of normal
* Left ventricular ejection fraction (LVEF) \> 40% OR normal electrocardiogram (EKG or ECG) and no history of cardiac disease
* All patients must be evaluated in the Department of Genitourinary Medical Oncology at M. D. Anderson Cancer Center or participating CCOP center prior to signing informed consent.
* No prior systemic chemotherapy including, adjuvant or neoadjuvant therapy
* Prior intravesicular chemotherapy allowed
Exclusion Criteria:
* No brain metastases
* Not pregnant or nursing
* No severe or uncontrolled infection
* No New York Heart Association class III-IV congestive heart failure, unstable angina, or history of myocardial infarction within the past 6 months
* No peripheral neuropathy \>= grade 2
* No persistently uncontrolled diabetes mellitus
* No chronic liver disease
* No HIV positivity
* No other malignancy except nonmelanoma skin cancer unless disease-free for the past 3 years
* No overt psychosis, mental disability, or other condition that would preclude giving informed consent
* No known sickle cell disease
* No uncontrolled severe hypertension
* Renal insufficiency that requires hemodialysis or renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00478361
Study Brief:
Protocol Section:
NCT00478361