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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Invasive Papillary Carcinoma of Bladder
• Intervention / Treatment: Drug: Oncofid-P-B

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45122
    • Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi
  • Mainz, Germany, 55131
    • Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Mülheim, Germany, D-45468
    • Praxisklinik Urologie Rhein-Ruhr
• Italy
  • Bari, Italy, 70124
    • A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi
  • Brescia, Italy, 25123
    • A.O. Spedali Civili di Brescia - Dipartimento di Urologia
  • Pisa, Italy, 56124
    • Azienda Ospedaliera Universitaria di Pisa - U.O. Urologia Universitaria
  • Roma, Italy, 00168
    • Policlinico A.Gemelli - Università Cattolica del Sacro Cuore - Dipartimento di Scienze Chirurgiche - Clinica Urologica
  • Torino, Italy, 10126
    • A.O.Città della Salute e della Scienza di Torino - Ospedale Molinette Dipartimento di Urologia I
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Valencia, Spain, 460009
    • Instituto Valenciano de Oncología
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Hospital Universitario Fundacion Alcorcon
    • Coslada, Madrid, Spain, 28820
      • Hospital del Henares
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Tenerife Hospital Universitario de Canarias

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).

Collaborators and Investigators

• Sponsor: Fidia Farmaceutici s.p.a.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2010
• Primary Completion (Actual): July 29, 2015
• Study Completion (Actual): October 4, 2016

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: paclitaxel; bladder cancer; hyaluronic acid
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Neoplasms, Squamous Cell; Urinary Bladder Neoplasms; Carcinoma, Papillary
• Other Study ID Numbers: R39-09-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No