ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.

NCT ID: NCT04661826

Last Updated: 2020-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-17
• Study Completion Date: 2016-10-04

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.

Conditions

Non-Invasive Papillary Carcinoma of Bladder

Keywords

paclitaxel; bladder cancer; hyaluronic acid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Oncofid-P-B

Intervention Type: DRUG

Paclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration.

Interventions

Oncofid-P-B

Paclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fidia Farmaceutici s.p.a.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , Germany

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, , Italy

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Hospital del Henares

Coslada, Madrid, Spain

Tenerife Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital Del Mar

Barcelona, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Instituto Valenciano de Oncologià

Valencia, , Spain

Countries

Germany; Italy; Spain

Other Identifiers

R39-09-01

Identifier Type: -

Identifier Source: org_study_id