Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O… (NCT03532139) | Clinical Trial Compass
CompletedPhase 2
Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)
United States24 participantsStarted 2018-07-25
Plain-language summary
This research study is studying a combination of two drug interventions called rosuvastatin and enoxaparin as a possible preventative measure against developing venous blood clots (such deep vein thrombosis or pulmonary embolism). .
The drugs involved in this study are:
* Rosuvastatin, also known as Crestor
* Enoxaparin
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Histologic diagnosis of ovarian, fallopian or primary peritoneal cancer (excluding borderline histologies). Preliminary pathology results based on frozen section findings are acceptable.
* The interval between pelvic or abdominal surgery and first dose of study treatment must be no more than 10 days.
* Age ≥ 18 years.
* ECOG performance status ≤2 (see Appendix A)
* Life expectancy of greater than 6 months
* Participants must have normal organ and marrow function as defined below:
* Platelets ≥ 100,000/mcL
* Total Bilirubin \<1.5 mg/dL (or direct bilirubin \<1.0 mg/dL)
* AST(SGOT) ≤ 1.5 × institutional upper limit of normal
* ALT(SGPT) ≤ 1.5 × institutional upper limit of normal
* Creatinine \< 1.5 mg/dL OR
* Estimated creatinine clearance ≥60 mL/min/1.73 m2
* The effects of rosuvastatin on the developing human fetus are unknown. For this reason and because statins used in this trial are thought to be teratogenic, women of child-bearing potential and men 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 she or her partner is participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Participants who are receiving any other investiga…
What they're measuring
1
Comparison of differences in circulating tissue factor bearing microparticles between study arms