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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000192-17-GB
Enrollment
28
Registered
2005-04-25
Start date
2005-05-18
Completion date
Unknown
Last updated
2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic transitional cell carcinoma of the urinary tract

Interventions

Trade Name: Gemzar Product Name: Gemcitabine Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Gemcitabine Hydrochloride Current Sponsor code: L01 BC05 Concentrati

Sponsors

Barts & The London NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Main Objective: Treatment response. ;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—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026