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

• Status: Completed
• Trial end date: 2016-10-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fidia Farmaceutici s.p.a.

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.