A randomized phase II study in the advanced or metastatic transitional cell urotelium carcinoma between Gemcitabine + Cisplatin e Gemcitabine + Cisplatino + Taxolo - ND
- Conditions
- Advanced transitional cell bladder carcinomaMedDRA version: 9.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2006-002737-21-IT
- Lead Sponsor
- OSPEDALE ONCOLOGICO DI BARI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Locally advanced (T4b) or metastatic (N2,N3, or M1) Transitional cell urotelium carcinoma
2. Age <= 70 years old
3. Presence of measurable lesions
4. Any previous chemotherapy or immunotherapy
5. Life expectancy of 12 weeks at least
6. Appropriate bone marrow activity
7. Appropriate liver functionality
Are the trial subjects under 18? no
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. Infections
2. Syntomatic SNC metastasis
3. Pregnancy and breast-feeding
4. Severe anomalies incompatible with the study
5. A second primary tumour
6. Administration of any other experimental drug during the previous month
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method