ONCOFID-P-B, a new anticancer drug for the treatment of bladder cancer

Phase 1

Conditions: Male and females patients affected by multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder will be inlcuded in the study.
MedDRA version: 18.1Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-012274-13-DE

Lead Sponsor: Fidia Farmaceutici S.p.A

Brief Summary: Not available

Detailed Description: Not available

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 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
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Hypersensitivity to Paclitaxel or one of its constituents;
- T1 papillary cancer or muscle-invasive disease (T2-T4) ;
- Previous or concomitant cancer of the upper urinary tract, of the prosthatic urethra, carcinoma in situ (CIS);
- Any other malignancy diagnosed within 3 years of study entry (except basal or sqamous 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 drugs 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.