Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis (NCT02968810) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis
United States, Puerto Rico52 participantsStarted 2017-06-21
Plain-language summary
This phase II trial studies how well simvastatin works in preventing liver cancer in patients with liver cirrhosis. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Confirmed diagnosis of liver cirrhosis assessed by the presence of clinical signs, symptoms, body imaging (ultrasound, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]), or liver biopsy
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
* Leukocytes \>= 2,500/microliter
* Absolute neutrophil count \>= 1,500/microliter
* Platelets \>= 50,000/microliter
* Hemoglobin \>= 8 g/dL
* Total bilirubin =\< 3 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional ULN
* Creatinine =\< 1.5 x institutional ULN
* Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women \>= 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test
* The effects of simvastatin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women who are able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participat…