Gemcitabine and Oxaliplatin in the treatment of locally advanced or metastatic transitional cell carcinoma of the urinary tract in patients with impaired renal function and patients who have progressed on a cisplatin-based regimen - GO-80 protocol in TCC urinary tract
- Conditions
- ocally advanced or metastatic transitional cell carcinoma of the urinary tract
- Registration Number
- EUCTR2005-000192-17-GB
- Lead Sponsor
- Barts & The London NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
1. Locally-invasive or metastatic transitional cell carcinoma of the urinary tract – from the renal pelvis to the bladder.
2. Males and females >16 years of age.
3. Life expectancy >12 weeks.
4. ECOG performance status 0–3 (see appendix).
5. Adequate bone marrow function (to be determined within 14 days of randomisation):
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Previous chemotherapy with gemcitabine or oxaliplatin
2. Untreated patients with a creatinine clearance > 60 ml/min
3. Concurrent participation in any other investigational drug study.
4. Unable to give written informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Treatment response.<br><br><br>;Secondary Objective: Evaluate treatment toxicity, quality of life (using the EORTC QLQ-C30 and EORTC QLQ-BLS24 quality of life assessments), progression-free survival and overall survival;Primary end point(s): Treatment response
- Secondary Outcome Measures
Name Time Method