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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT00627432
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed urothelial carcinoma, or transitional cell carcinoma of the bladder or upper urinary tract
* Locally advanced disease (T4b) or metastatic disease (N2, N3, or M1)
* Unable to receive cisplatin-based chemotherapy due to creatinine clearance 30-60 mL/min or performance status 2
* At least 1 unidimensionally measurable lesion according to RECIST criteria
* No nonmeasurable lesions only, including any of the following:
* Ascites
* Pleural or pericardial effusion
* Bone metastases
* Lymphangitis
* No symptomatic cerebral metastases unless they have been stabilized
PATIENT CHARACTERISTICS:
* See Disease Characteristics
* Performance status 0-2
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
* Transaminases ≤ 2 times normal (5 times normal if hepatic metastases present)
* Bilirubin ≤ 1.5 times normal
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for at least 6 months after completion of treatment
* No prior malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
* No peripheral neuropathy ≥ grade 2
* No uncontrolled infection
* No other medical conditions that could interfere with evaluating tolerability, including any of the following:
* Congestive heart failure
* Angina pectoris that cannot be stabilized with medication
* Myocardial infarction within the past 12 months
* Serious thromboembolic disease
* No psychologic, social, or geographic reason that would make follow-up impossible
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy for advanced disease
* More than 4 weeks since prior radiotherapy to a target measurable lesion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00627432
Study Brief:
Protocol Section:
NCT00627432