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.

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.

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.