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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2025
  • participants needed
    49
  • sponsor
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Updated on 1 February 2021
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 urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Superficial Bladder Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, bladder tumor
Treatment Metformin
Clinical Study IdentifierNCT03379909
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last Modified on1 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Superficial Bladder Cancer or bladder cancer?
Do you have any of these conditions: bladder tumor or bladder disorder or bladder cancer or carcinoma of the bladder or Urothelial Cancer or urinary tract neoplasm or Bladder Carcinoma or...?
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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