ONCOFID-P (Paclitaxel-hyaluronic acid) in the intravesical therapy of patients with non-muscle invasive cancer of the bladder. A phase II marker lesion study - ND

Phase 1

• Conditions: Patients affected by multiple recurrent Ta G1-G2 papillary cancer of the bladder.; MedDRA version: 9.1Level: LLTClassification code 10005003

• Registration Number: EUCTR2009-012274-13-IT
• Lead Sponsor: FIDIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-09
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 recurrent Ta G1-G2 papillary cancer; ECOG Performance Status 0 to 1 ; Adequate bone marrow function: neutrophils = o sup. 1.500 mL; platelet count = o sup. 100.000 mm3; Hb = o sup. 10 g/dL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hypersensitivity to Paclitaxel or one of its constituents; T1 and Muscle-invasive disease (T2-T4). Previous or concomitant cancer of the upper urinary tract, of the prosthatic urethra, carcinoma in situ (CIS); Any previous or concomitant malignancies other than superficial bladder cancer; Presence of significant urologic disease interfering with intravesical therapy; Other chemotherapy or radiotherapy within four weeks of study entry; Previous intravesical immunotherapy or chemotherapy less than 3 months before study entry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified