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

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    40
  • sponsor
    Beth Israel Deaconess Medical Center
Updated on 21 February 2021
direct bilirubin
peritoneal cancer
primary peritoneal carcinoma
cancer of the ovary
surgery for ovarian cancer

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

Description

This is a randomized pilot trial to estimate the effect of rosuvastatin on levels of tissue factor bearing microparticles (TFMP) in patients undergoing surgery for presumed ovarian cancer (including primary peritoneal and fallopian tube carcinoma). Women will either be randomized to enoxaparin subcutaneously once daily (Arm A) or enoxaparin in combination with rosuvastatin (Arm B). Arm C will receive thromboprophylaxis according to standard of care and not be randomized. Levels of circulating TFMP will be assessed in all patients on Day 1 and following surgery (days 15, 30 and day 60). A bilateral lower extremity ultrasound will be performed on days 30 and 60 for all participants to estimate the rate of VTE in the 3 arms.

Details
Condition Ovarian disorder, Ovarian Cancer, Ovarian Function, Recurrent Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors
Treatment Enoxaparin, Enoxaparin + Rosuvastatin, Thromboprophylaxis, Thromboprophylaxis
Clinical Study IdentifierNCT03532139
SponsorBeth Israel Deaconess Medical Center
Last Modified on21 February 2021

Eligibility

Yes No Not Sure

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 investigational agents
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
Presence of coagulopathy defined as
PT > 1.3 x upper limit of normal
PTT > 1.3 x upper limit of normal
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
Familial bleeding diathesis
Known diagnosis of disseminated intravascular coagulation
Currently taking statin (i.e. rosuvastatin, atorvastatin, simvastatin) or fibrates
Currently receiving anticoagulant therapy
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
Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketoconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors
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
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
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