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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT00009867
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required
* Patients must have relapsed from or failed to achieve a complete or partial response after one chemotherapy regimen, which must have included one of the following chemotherapy agents: cisplatin, carboplatin paclitaxel, or gemcitabine
* \>= 4 weeks since prior RT or chemotherapy
* Patients must have measurable disease
* CTC (ECOG) Performance Status =\< 1
* No evidence of NYHA functional class III or IV heart disease
* Baseline EKG with QTc \< 500 ms
* Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study
* Granulocytes \> 1500/ml
* Platelet count \> 100,000/ml
* Bilirubin =\< Upper limits of normal (ULN)
* Serum Creatinine \< 2.0 x ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00009867
Study Brief:
Protocol Section:
NCT00009867