Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract
Phase 2
Terminated
- Conditions
- Carcinoma, Transitional Cell
- Registration Number
- NCT00127595
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Brief Summary
This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Transitional cell carcinoma
- Histologically-proven
- Locally advanced unresectable or metastatic
- With at least one measurable target
- Informed consent signed
Exclusion Criteria
- Previous chemotherapy
- Previous radiotherapy
- Performance status >=2
- Peripheral neuropathy >=1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
- Secondary Outcome Measures
Name Time Method overall survival disease free survival toxicity
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, France