ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.
- Registration Number
- NCT04661826
- Lead Sponsor
- Fidia Farmaceutici s.p.a.
- 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 primary and recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.
- 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 on a papillary marker tumor in patients suffering from non-muscle invasive cancer of the bladder. When a patient will present a Complete Response at the end of the six weekly administration of Oncofid-P-B , he/she can enter a second phase of the study defined maintenance phase. During this phase, the patients will be treated with the study drug administered by intravesical infusion once a month for 2 cycles of treatment with the duration of 6 months separated by a period during which study drug will not be administered, due to the necessity to perform histological evaluation of efficacy. This scheme will follow a clinical usual approach for the maintenance treatment of patients suffering from non-muscle invasive cancer of the bladder.
Complete Response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other site and negative cytology.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oncofid-P-B Oncofid-P-B Oncofid-P-B will be administered once a week for 6 weeks in the first treatment phase and once a month for 6 months followed by other 6 months in the second maintenance phase
- Primary Outcome Measures
Name Time Method CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor. Visit 8 will be performed 2-4 weeks after the last treatment visit (Visit 7) Rate of complete response, estimated at V8, after 6 weeks of weekly study drug administration: number and percentage of patients with complete response. Complete response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other sites and negative cytology.
- Secondary Outcome Measures
Name Time Method Time to relapse after Oncofid-P-B instillation during the maintenance phase. The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks). Time to relapse after Oncofid-P-B instillation during the maintenance phase.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0" The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks). Treatment-Related Adverse Events as Assessed by CTCAE v4.0" with Oncofid-P-B given by intravesical instillation.
Number of patients with relapse within V 22. The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks). Number of patients with relapse within V 22.
Trial Locations
- Locations (14)
Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi
🇩🇪Essen, Germany
A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi
🇮🇹Bari, Italy
Praxisklinik Urologie Rhein-Ruhr
🇩🇪Mülheim, Germany
A.O. Spedali Civili di Brescia - Dipartimento di Urologia
🇮🇹Brescia, Italy
Policlinico A.Gemelli - Università Cattolica del Sacro Cuore - Dipartimento di Scienze Chirurgiche - Clinica Urologica
🇮🇹Roma, Italy
A.O.Città della Salute e della Scienza di Torino - Ospedale Molinette Dipartimento di Urologia I
🇮🇹Torino, Italy
Hospital Del Mar
🇪🇸Barcelona, Spain
Tenerife Hospital Universitario de Canarias
🇪🇸La Laguna, Tenerife, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Instituto Valenciano de Oncologià
🇪🇸Valencia, Spain
Hospital del Henares
🇪🇸Coslada, Madrid, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Azienda Ospedaliera Universitaria di Pisa - U.O. Urologia Universitaria
🇮🇹Pisa, Italy