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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT00588666
Eligibility Criteria:
Inclusion Criteria:
* Histologic documentation: diagnosis of transitional cell carcinoma of the bladder,urethra, ureter, or renal pelvis.
* Unresectable or metastatic disease
* Ineligible for cisplatin (or incurable with cisplatin)
* ≥ 4 weeks since prior RT
* Karnofsky Performance Status ≥ 60%
* Age ≥ 18 years of age
* Required Initial Laboratory Values: Absolute neutrophil count ≥ 1.2 x 109/L; Platelets ≥ 100 x 109/L; Bilirubin ≤ 1.5 times the upper limit of normal (x ULN) for the institution; Aspartate transaminase (AST) and alanine transaminase(ALT) ≤ 3.0 x ULN;Serum creatinine \< 2.0 or calculated creatinine clearance (CrCl) ≥ 30 mL/min
Exclusion Criteria:
* Prior treatment with systemic chemotherapy (prior intravesical therapy is permitted)
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
* Blood pressure of \>150/100 mmHg
* Unstable angina
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of myocardial infarction within 6 months
* History of stroke within 6 months
* Clinically significant peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Presence of central nervous system or brain metastases
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0
* Anticipation of need for major surgical procedure during the course of the study
* Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
* Pregnant (positive pregnancy test) or lactating
* Albuminuria as demonstrated by a urinary albumin of greater or = to 1.0 g/24 hr at screening
* History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 6 months prior to Day 0
* Serious, non-healing wound, ulcer, or bone fracture
* Inability to comply with study and/or follow-up procedures
* History of persistent gross hematuria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00588666
Study Brief:
Protocol Section:
NCT00588666