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

Study Overview
=================
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.

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

Conditions
-----------------
Non-Invasive Papillary Carcinoma of Bladder

Intervention / Treatment
-----------------
* Drug: Oncofid-P-B


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oncofid-P-B<br>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<br>* Paclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration.<br>|

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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paclitaxel, bladder cancer, hyaluronic acid