oncofid-p-b in the intravescical therapy of patients with non-muscle invasive cancer of the bladder.

Conditions: Non-Invasive Papillary Carcinoma of Bladder

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.

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.

Keywords: paclitaxel bladder cancer hyaluronic acid