Non-Invasive Papillary Carcinoma of Bladder Clinical Trial
Official title:
ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder. A Phase II Marker Lesion. STUDY
| Verified date | December 2020 |
| Source | Fidia Farmaceutici s.p.a. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | October 4, 2016 |
| Est. primary completion date | July 29, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi | Essen | |
| Germany | Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | |
| Germany | Praxisklinik Urologie Rhein-Ruhr | Mülheim | |
| Italy | A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi | Bari | |
| Italy | A.O. Spedali Civili di Brescia - Dipartimento di Urologia | Brescia | |
| Italy | Azienda Ospedaliera Universitaria di Pisa - U.O. Urologia Universitaria | Pisa | |
| 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 | |
| Spain | Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid |
| Spain | Hospital Del Mar | Barcelona | |
| Spain | Hospital del Henares | Coslada | Madrid |
| Spain | Tenerife Hospital Universitario de Canarias | La Laguna | Tenerife |
| Spain | Hospital Clinico San Carlos | Madrid | |
| Spain | Instituto Valenciano de Oncologià | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Fidia Farmaceutici s.p.a. |
Germany, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor. | 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. | Visit 8 will be performed 2-4 weeks after the last treatment visit (Visit 7) | |
| Secondary | Time to relapse after Oncofid-P-B instillation during the maintenance phase. | 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). | |
| Secondary | Number of patients with relapse within V 22. | 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). | |
| Secondary | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0" | Treatment-Related Adverse Events as Assessed by CTCAE v4.0" with Oncofid-P-B given by intravesical instillation. | The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks). |