Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer (TROJAN)

STATUS

Recruiting
End date

Oct 1, 2025
participants needed

49
sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Updated on 23 February 2022

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cancer

carcinoma

EGFR

carcinoma in situ

metformin

bladder cancer

invasive bladder cancer

transitional cell carcinoma

transurethral resection

bladder tumor

bladder carcinoma

Summary

A multi-center, open-label, phase II clinical study of metformin in up to evaluable 49 patients with low-grade NMIBC with the aim to determine the overall response to administration of oral metformin for 3 months in a marker tumour deliberately left following transurethral resection of multiple, papillary NMIBC tumours.

Description

A multi-center, open-label, phase II clinical study of metformin in up to 49 patients with low-grade NMIBC with the aim to determine the overall response to administration of oral metformin for 3 months in a marker tumour deliberately left following transurethral resection of multiple, papillary NMIBC tumours. All patients will receive metformin orally at doses up to 1500 mg twice daily. Metformin treatment will start within 2 weeks following transurethral resection, in which all but the marker lesion will be resected. After 3 months of metformin treatment, the effect of metformin on the marker lesion is evaluated by cystoscopy and biopsy under anaesthesia. Residual tumour, if present at this evaluation, will be resected. In case of complete disappearance of the marker lesion the former tumour area will be biopsied.

Details

Condition	Superficial Bladder Cancer, Bladder Cancer
Treatment	Metformin
Clinical Study Identifier	NCT03379909
Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on	23 February 2022

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Eligibility		Yes	No	Not Sure
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 2 lesions but no more than 10
	The resected lesions must contain detrusor muscle to confirm a Ta/T1 disease
	All visible lesions must be completely removed by transurethral resection at entry to the study, except for an untouched marker lesion measuring 0.5-1.0 cm in its greatest dimension
	Bimanual examination immediately following transurethral resection under anaesthesia should be carried out and no mass should be felt
	Adequate renal function (creatinine <150 mol/L and/or an eGFR >60 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

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Phase II Study of Oral Metformin for Intravesical Treatment of Non-muscle-invasive Bladder Cancer (TROJAN)