Status:
COMPLETED
ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.
Lead Sponsor:
Fidia Farmaceutici s.p.a.
Conditions:
Non-Invasive Papillary Carcinoma of Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple primar...
Detailed Description
This study will investigate the preliminary activity of Oncofid-P-B administered by intravescical route at the Recommended Dose of 600 mg, once a week, for six weeks evaluating the ablative activity o...
Eligibility Criteria
Inclusion
- Patients of both sexes aged \> 18 years, women in menopause (defined as surgically sterile or one year postmenopausal);
- Cytological or histological diagnosis of bladder cancer;
- Multiple primary or recurrent Ta G1-G2 papillary cancer;
- ECOG Performance Status 0 to 1;
- Adequate bone marrow function: neutrophils ≥1.5 103/mL; platelet count ≥100 103/ mm3; Hb ≥ 10 g/dL;
- Written informed consent;
- Willing and able to comply with the protocol for the duration of the study.
Exclusion
- Hypersensitivity to Paclitaxel or one of its constituents;
- T1 papillary cancer or muscle-invasive disease (T2-T4) ;
- Previous or concomitant tumor of the upper urinary tract, of the prostatic urethra, CIS;
- Any other malignancy diagnosed within 3 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix);
- Presence of significant urologic disease interfering with intravesical therapy;
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening or concurrent treatment with other experimental drugs;
- Other chemotherapy or radiotherapy within four weeks of study entry;
- Previous intravesical immunotherapy or chemotherapy less than 3 months before study entry;
- Bladder capacity less than 300 mL;
- Renal and hepatic function values exceeding 2 times the upper normal value;
- Severe cardiovascular diseases considered a contraindication to intravesical treatment;
- Pregnant, lactating or childbearing potential aged women.
Key Trial Info
Start Date :
May 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04661826
Start Date
May 17 2010
End Date
October 4 2016
Last Update
December 10 2020
Active Locations (14)
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1
Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi
Essen, Germany, 45122
2
Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
3
Praxisklinik Urologie Rhein-Ruhr
Mülheim, Germany, D-45468
4
A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi
Bari, Italy, 70124