ONCOFID-P-B (Paclitaxel-Hyaluronic Acid) In The Intravesical Therapy Of Patients With Non-Muscle Invasive Cancer Of The Bladder. A Phase II Marker Lesion Study.

Fidia Farmaceutici S.p.A0 个研究点目标入组 60 人开始时间: 2009年12月14日最近更新: 2017年10月9日

适应症

试验速览

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•- 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

•- 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.

发起方

Fidia Farmaceutici S.p.A