Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion (NCT02581137) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion
United States, Canada26 participantsStarted 2016-06-10
Plain-language summary
This phase IIa trial studies how well metformin hydrochloride works in preventing oral cancer in patients with an oral premalignant lesion (oral leukoplakia or erythroplakia). Oral premalignant lesions look like red or whitish plaques or lesions in the mouth that do not rub off and can be associated with a higher risk of cancer. Metformin hydrochloride may help prevent oral cancer from forming in patients with an oral premalignant lesion.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants with oral leukoplakia or erythroplakia with mild, moderate, or severe histologic dysplasia, or hyperplasia not associated with mechanical factors such as ill-fitted dentures
* Measurable disease - minimum lesion size of 8 x 3 mm before initial biopsy
* Karnofsky performance status \>= 70%
* Leukocytes \>= 3,000/microliter
* Absolute neutrophil count \>= 1,000/microliter
* Platelets \>= 100,000/microliter
* Total bilirubin =\< 1.5 Ă— institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\<1.5 Ă— institutional ULN
* eGFR \> 40 mL/min using the Cockcroft-Gault equation
* Life expectancy \> 3 months
* Willing to use adequate contraception (barrier method, abstinence, subject has had a vasectomy or partner is using effective birth control or is postmenopausal) for the duration of study participation
* Ability to take oral medication
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with diabetes who are taking insulin or oral agents
* History of diabetic ketoacidosis
* Participants may not be receiving any other investigational agents within past 3 months
* History of allergic reactions attributed to compounds of similar chemical composition to metformin or prior use of metformin within the last year
* Uncontrolled intercurre…