Advanced transitional cell bladder carcinoma MedDRA version: 9.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GEMZAR*INFUS 1FL 1G POLV
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Gemcitabine
CAS Number: 122111-03-9
Concentration unit: g gram(s)
Concentration typ
Sponsors
OSPEDALE ONCOLOGICO DI BARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Locally advanced (T4b) or metastatic (N2,N3, or M1) Transitional cell urotelium carcinoma 2. Age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To estimate the percentage of response in patients with advanced and/or metastatic urotelium carcinoma treated with Gemcitabine + Cisplatin (GC) e Gemcitabine + Cisplatin + Taxol (GCT) 2. To estimate the tolerance of this combination of drugs;Secondary Objective: 1. To estimate the duration of the response 2. To estimate the time to progression and failure of the therapy 3. To estimate the survival 4. To characterize the nature of the observed toxicity To estimate the changing of life quality through the EORTC QLQ C-30;Primary end point(s): To estimate the efficacy of the combination Gemcitabine + Cisplatin (GC) and Gemcitabine + Cisplatin + Taxol (GCT) | — |
Countries
Italy
Outcome results
None listed