Pharmacokinetical-clinical study of intravescical gemcitabine in patients with marker lesion of superficial transitional cell carcinoma of the bladder - ND
- Conditions
- Patients with superficial transitional cell carcinoma of the bladderMedDRA version: 6.1Level: PTClassification code 10005003
- Registration Number
- EUCTR2007-001942-42-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br><br>pH of the instilled solution: pH 2.7-3.2 (unbuffered solution) or pH 5.5 (buffered solution)<br><br>dwell time: 1 hour or 2 houres<br><br>concentration of gemcitabine (20 mg/ml or 40 mg/ml);Secondary Objective: The aim of the pharmacokinetic study is to:<br><br>defining the plasmatic pharmacokinetics of gemcitabine and dFdU during and after the dwelling time of gemcitabine<br><br>evaluate the concentration of gemcitabine and dFdU in the voided urine collected at the end of instillation <br><br>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
- Secondary Outcome Measures
Name Time Method