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Impact of Rosuvastatin on Risk Markers of Venous Thromboembolism During Systemic Therapy for Advanced Cancer

Phase 2
18 Years
Open (Enrolling)
Venous Thromboembolism, Deep Vein Thrombosis, Neoplasms

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Trial Information

Impact of Rosuvastatin on Risk Markers of Venous Thromboembolism During Systemic Therapy for Advanced Cancer

Inclusion Criteria:

- Adult patients > 18 years old with locally-advanced or metastatic cancers who are
about to start or are already receiving any systemic chemotherapy or targeted

- Estimated overall survival of ≥ 6 months

- Anticipated duration of therapy ≥ 9 weeks (if 3-week cycle) or ≥ 12 weeks (if 2 or
4-week cycle). Systemic therapy is allowed to change if necessary, or to terminate,
during this period

Exclusion Criteria:

- Antithrombotic therapy including warfarin, dabigatran, low molecular weight heparin
or unfractionated heparin. Patients taking aspirin may participate in this study.

- Anti-angiogenic therapy with thalidomide or lenalidomide. Patients receiving
bevacizumab may participate in this study.

- Patients starting hormonal therapy exclusively, such as SERM or aromatase inhibitor
therapy for breast cancer, or androgen-ablative therapy for prostate cancer.

- Statin use within 3 months prior to enrolment

- Adjuvant therapy in patients who have already received curative-intent local therapy
(surgery or radiotherapy). Patients with glioblastoma starting adjuvant chemotherapy
are an exception given the high likelihood of residual disease and risk of VTE in
this population.

- Asian descent as assessed by history. If either of the participant's parents is Asian
(peoples of East, Southeast, and South Asia), a patient will be excluded due to
slower metabolism of the drug and concerns regarding toxicity at the 20 mg dose

- Urinary creatinine clearance of less than 40 ml/min based on reported MDRD GFR,
present in FAHC metabolic profile reports, during the 14 day screening period.

- AST or ALT elevation of greater than 3X upper limit of normal, during the 14 day
screening period.

- Patients with a known history of statin intolerance that was accompanied by severe
adverse reaction.

- Patients who are currently participating in another clinical trial involving an
investigational medication if there is a known or suspected drug interaction with
rosuvastatin or the statin class, or if the investigational agent is known or
suspected to be associated with a significantly increased risk of thrombosis.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

To determine if rosuvastatin therapy reduces the risk of VTE in patients with cancer receiving chemotherapy, as measured by a decrease in D-dimer level with treatment compared to placebo

Outcome Time Frame:

baseline, 3-4 weeks, 6-9 weeks, 9-13 weeks (ranges depending one treatment period lengths set for each patient at enrollment)

Safety Issue:


Principal Investigator

Steven Ades, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Vermont


United States: Institutional Review Board

Study ID:

VCC 1110



Start Date:

March 2012

Completion Date:

August 2013

Related Keywords:

  • Venous Thromboembolism
  • Deep Vein Thrombosis
  • Neoplasms
  • VTE
  • DVT
  • Chemo
  • Metastatic
  • Advanced
  • Systemic therapy
  • statin
  • biomarkers
  • Neoplasms
  • Thromboembolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism



Fletcher Allen Health Care Burlington, Vermont  05401