Clinical trial NCT04661826: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Invasive Papillary Carcinoma of Bladder
Keywords: paclitaxel
bladder cancer
hyaluronic acid
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2020-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor.
timeFrame: Visit 8 will be performed 2-4 weeks after the last treatment visit (Visit 7)
Secondary outcomes:
measure: Time to relapse after Oncofid-P-B instillation during the maintenance phase.
timeFrame: The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).
measure: Number of patients with relapse within V 22.
timeFrame: The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0"
timeFrame: The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Klinik und Poliklinik für Urologie, Kinderurologie und Onkologische Urologi
city: Mainz
country: Germany
facility: Urologische Klinik und Poliklinik - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Mülheim
country: Germany
facility: Praxisklinik Urologie Rhein-Ruhr
city: Bari
country: Italy
facility: A.O.Universitaria - Ospedale Consorziale Policlinico di Bari - Urologia - Dipartimento d'Emergenza e dei Trapianti di Organi
city: Brescia
country: Italy
facility: A.O. Spedali Civili di Brescia - Dipartimento di Urologia
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria di Pisa - U.O. Urologia Universitaria
city: Roma
country: Italy
facility: Policlinico A.Gemelli - Università Cattolica del Sacro Cuore - Dipartimento di Scienze Chirurgiche - Clinica Urologica
city: Torino
country: Italy
facility: A.O.Città della Salute e della Scienza di Torino - Ospedale Molinette Dipartimento di Urologia I
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Coslada
country: Spain
facility: Hospital del Henares
state: Madrid
city: La Laguna
country: Spain
facility: Tenerife Hospital Universitario de Canarias
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologià
Study officials:
References: