Phase II study of oral metformin for intravesical treatment of non-muscle-invasive bladder cancer

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 49

Inclusion Criteria

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
up.

Exclusion Criteria

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
cystitis.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials