Back to resultsONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.
Primary Purpose
Non-Invasive Papillary Carcinoma of Bladder
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oncofid-P-B
Sponsored by
About this trial
This is an interventional treatment trial for Non-Invasive Papillary Carcinoma of Bladder focused on measuring paclitaxel, bladder cancer, hyaluronic acid
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.
Sites / Locations
- Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi
- Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Praxisklinik Urologie Rhein-Ruhr
- A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi
- A.O. Spedali Civili di Brescia - Dipartimento di Urologia
- Azienda Ospedaliera Universitaria di Pisa - U.O. Urologia Universitaria
- Policlinico A.Gemelli - Università Cattolica del Sacro Cuore - Dipartimento di Scienze Chirurgiche - Clinica Urologica
- A.O.Città della Salute e della Scienza di Torino - Ospedale Molinette Dipartimento di Urologia I
- Hospital Universitario Fundación Alcorcón
- Hospital del Henares
- Tenerife Hospital Universitario de Canarias
- Hospital Del Mar
- Hospital Clinico San Carlos
- Instituto Valenciano de Oncologià
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oncofid-P-B
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to relapse after Oncofid-P-B instillation during the maintenance phase.
Time to relapse after Oncofid-P-B instillation during the maintenance phase.
Number of patients with relapse within V 22.
Number of patients with relapse within V 22.
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.
Full Information
NCT ID
NCT04661826
First Posted
December 2, 2020
Last Updated
December 8, 2020
Sponsor
Fidia Farmaceutici s.p.a.
1. Study Identification
Unique Protocol Identification Number
NCT04661826
Brief Title
ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 17, 2010 (Actual)
Primary Completion Date
July 29, 2015 (Actual)
Study Completion Date
October 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidia Farmaceutici s.p.a.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Invasive Papillary Carcinoma of Bladder
Keywords
paclitaxel, bladder cancer, hyaluronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oncofid-P-B
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Oncofid-P-B
Intervention Description
Paclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration.
Primary Outcome Measure Information:
Title
CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor.
Description
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.
Time Frame
Visit 8 will be performed 2-4 weeks after the last treatment visit (Visit 7)
Secondary Outcome Measure Information:
Title
Time to relapse after Oncofid-P-B instillation during the maintenance phase.
Description
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).
Title
Number of patients with relapse within V 22.
Description
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).
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0"
Description
Treatment-Related Adverse Events as Assessed by CTCAE v4.0" with Oncofid-P-B given by intravesical instillation.
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Praxisklinik Urologie Rhein-Ruhr
City
Mülheim
ZIP/Postal Code
D-45468
Country
Germany
Facility Name
A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
A.O. Spedali Civili di Brescia - Dipartimento di Urologia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Pisa - U.O. Urologia Universitaria
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Policlinico A.Gemelli - Università Cattolica del Sacro Cuore - Dipartimento di Scienze Chirurgiche - Clinica Urologica
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O.Città della Salute e della Scienza di Torino - Ospedale Molinette Dipartimento di Urologia I
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Hospital Universitario Fundación Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital del Henares
City
Coslada
State/Province
Madrid
ZIP/Postal Code
28820
Country
Spain
Facility Name
Tenerife Hospital Universitario de Canarias
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Instituto Valenciano de Oncologià
City
Valencia
ZIP/Postal Code
460009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
ONCOFID-P-B in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder.
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