Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)

Prior treatment

• Participants who are receiving any other investigational agents.
• Uncontrolled hypothyroidism (defined as TSH below lower limit of normal). Qualifying TSH may be within 60 days prior to enrollment. If screening TSH is low, patients are eligible if free T4 is within normal limits.
• Currently taking statin (i.e. rosuvastatin, atorvastatin, simvastatin) or fibrates
• Currently receiving anticoagulant therapy
• Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketoconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors

Other illness

• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and increased risk of intracranial hemorrhage
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to enoxaparin or atorvastatin
• Active bleeding or high risk of bleeding (e.g. known acute gastrointestinal ulcer)
• History of heparin-induced thrombocytopenia.
• Any history of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last year.
• Familial bleeding diathesis
• Known recent history of heavy alcohol use
• History of rhabdomyolysis while on statin therapy.
• Known active Hepatitis C or active Hepatitis B infection.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Lab values

• Presence of coagulopathy defined as:
  • PT \> 1.3 x upper limit of normal
  • PTT \> 1.3 x upper limit of normal

Other

• Known diagnosis of disseminated intravascular coagulation
• Current use of aspirin (\>81 mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox).
• Known Asian descent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin) due to altered metabolism of statins.
• Pregnant women are excluded from this study due to the potential for teratogenic effects on the human fetus. Because there is an unknown but potential risk of adverse events in nursing infants secondary to the treatment of the mother with rosuvastatin, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.

• 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