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

• ClinicalTrials.gov Identifier: NCT04661826
• Recruitment Status: Completed
• First Posted: December 10, 2020
• Last Update Posted: December 10, 2020
• Sponsor: Fidia Farmaceutici s.p.a.
• Information provided by (Responsible Party): Fidia Farmaceutici s.p.a.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Invasive Papillary Carcinoma of Bladder	Drug: Oncofid-P-B	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 17, 2010
• Actual Primary Completion Date: July 29, 2015
• Actual Study Completion Date: October 4, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: Oncofid-P-B; Paclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration.

Outcome Measures

Primary Outcome Measures :

1. CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor. [ Time Frame: 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 :

1. Time to relapse after Oncofid-P-B instillation during the maintenance phase. [ Time Frame: 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.
2. Number of patients with relapse within V 22. [ Time Frame: 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.
3. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0" [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Germany

Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi

Essen, Germany, 45122

Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany, 55131

Praxisklinik Urologie Rhein-Ruhr

Mülheim, Germany, D-45468

Italy

A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi

Bari, Italy, 70124

A.O. Spedali Civili di Brescia - Dipartimento di Urologia

Brescia, Italy, 25123

Azienda Ospedaliera Universitaria di Pisa - U.O. Urologia Universitaria

Pisa, Italy, 56124

Policlinico A.Gemelli - Università Cattolica del Sacro Cuore - Dipartimento di Scienze Chirurgiche - Clinica Urologica

Roma, Italy, 00168

A.O.Città della Salute e della Scienza di Torino - Ospedale Molinette Dipartimento di Urologia I

Torino, Italy, 10126

Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain, 28922

Hospital del Henares

Coslada, Madrid, Spain, 28820

Tenerife Hospital Universitario de Canarias

La Laguna, Tenerife, Spain, 38320

Hospital Del Mar

Barcelona, Spain, 08003

Hospital Clinico San Carlos

Madrid, Spain, 28040

Instituto Valenciano de Oncologià

Valencia, Spain, 460009

Sponsors and Collaborators

Fidia Farmaceutici s.p.a.

More Information

• Responsible Party: Fidia Farmaceutici s.p.a.
• ClinicalTrials.gov Identifier: NCT04661826
• Other Study ID Numbers: R39-09-01
• First Posted: December 10, 2020
• Last Update Posted: December 10, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fidia Farmaceutici s.p.a.:

paclitaxel; bladder cancer; hyaluronic acid

Additional relevant MeSH terms:

Carcinoma, Papillary; Urinary Bladder Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urinary Bladder Diseases; Urologic Diseases