NL-OMON56329已完成2 期
Phase II study of oral metformin for intravesical treatment of non-muscle-invasive bladder cancer - TROJA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Age > 18 years. Patients with primary or recurrent multiple histologically
- •confirmed Ta or T1 (non-muscle invasive), G1 or G2 (low grade) urothelial
- •carcinoma of the bladder with no evidence of carcinoma in situ. Patients must
- •have at least 1 lesion but no more than 5. Bimanual examination immediately
- •following transurethral resection under anaesthesia should be carried out and
- •no mass should be felt. Adequate renal function (creatinine <150 µmol/L and/or
- •an eGFR >>50 ml/L). Adequate liver function (bilirubin <1.5 times upper limit
- •of normal, ALAT or ASAT <2.5 the upper limit of normal). Eligible patients must
- •be fully informed of the investigational nature of the study and written signed
- •informed consent must be obtained prior to any study specific investigations.
- •Mentally, physically, and geographically able to undergo treatment and follow
排除标准
- •Patients having muscle-invasive disease (stage T2 or greater) or CIS.
- •Patients with grade 3 (high-grade) tumours.
- •Patients with diabetes mellitus receiving metformin or having received
- •metformin in the past 6 months.
- •Patients who have received intravesical treatment (chemotherapy or
- •immunotherapy) within the last 3 months.
- •Patients that are currently receiving other anti-cancer therapy.
- •Patients with existing urinary tract infection or recurrent severe bacterial
- •Patients that need to be treated with a transurethral catheter.
- •Patients with urogenital tumours with histology other than urothelial carcinoma
- •(i.e. squamous cell or adenocarcinoma) or with urothelial carcinoma involving
- •the upper tract or the prostatic urethra.
- •Patients with a history of other primary malignancy (other than squamous or
- •basal cell skin cancers or cone biopsied CIS of the uterine cervix or prostate
- •carcinoma treated curatively with normal PSA values at inclusion) in the last
- •five years.
- •Patients with active, uncontrolled impairment of the renal, hepatobiliary,
- •cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic
- •systems that, in the opinion of the investigator, would predispose to the
- •development of complications from the administration of metformin.
- •Patients who are using loop diuretics, cimetidine, ranitidine, cetirizine,
- •trimethoprim, vandetanib, kinidine and/or HIV medication, for which no
- •reasonable alternative is available.
- •Women who are pregnant or lactating. Individuals of reproductive potential may
- •not participate unless agreeing to use an effective contraceptive method for
- •themselves and/or their sexual partner.
- •Patients with ECOG-WHO performance status of 3 or 4.
- •Patients with a known history of alcohol abuse.
- •Patients with a known hypersensitivity to metformin.
- •Patients who in the investigator's opinion, cannot comply with provisions of
- •the protocol or do not understand the nature of the study.
研究者
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