E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with superficial transitional cell carcinoma of the bladder |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10005003 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Disappiearance of marker lesion |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
stesso farmaco con somministrazione diversa |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |