Patients with superficial transitional cell carcinoma of the bladder MedDRA version: 6.1 Level: PT Classification code 10005003
Conditions
Interventions
Trade Name: GEMZAR
Pharmaceutical Form: Powder for bladder irrigation
INN or Proposed INN: Gemcitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2000-
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with superficial transitional cell carcinoma of the bladder with 1 or more lesions 1 to 3 cm in size, new diagnosis or recurrent. Informed consent obtained  18 years old. ECOG Performance Status  2. Adequate marrow function: PTL  100.000/mm3, Hb  9 g/dl, neutrophil  1500/mm3; Adequate renal function: serum creatinine less than 2 times the upper limit of normal; Adequate hepatic function: bilirubin, AST and ALT less than 2 times the upper limit of normal. 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
Exclusion criteria
Exclusion criteria: Invasive bladder cancer Urinary citology positive to high degree atipie Bladder capacity less than 150 ml or urinary interval less than 2 houres. Concurred malignancy or immunodepression Creatininemie or hepatic function more than 2.5 times the upper limit of normal Pregnancy or lactation Cardiopatie NYHA Class II or more with congestive cardiac failure. Uncontrollable bacterial, viral or fungine infection Confusional State or time/space disorientation. Every medical, psycological or social condition that could influence a suitable follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Disappiearance of marker lesion;Main Objective: The aim of this study is to define the optimal values of the next parameters for the intravescical administration of gemcitabine 20000 mg: pH of the instilled solution: pH 2.7-3.2 (unbuffered solution) or pH 5.5 (buffered solution) dwell time: 1 hour or 2 houres concentration of gemcitabine (20 mg/ml or 40 mg/ml);Secondary Objective: The aim of the pharmacokinetic study is to: defining the plasmatic pharmacokinetics of gemcitabine and dFdU during and after the dwelling time of gemcitabine evaluate the concentration of gemcitabine and dFdU in the voided urine collected at the end of instillation evaluate the level of gemcitabine, dFdU and gemcitabine triphosphate on samples of tumor and normal tissue of bladder collected during TUR (transurethral resection) performed immediately after the administration of gemcitabine | — |
Countries
Italy
Outcome results
None listed