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Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04457089
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Bobbie Jo Rimel, MD, Cedars-Sinai Medical Center

Brief Summary:
This is a single arm pilot trial to evaluate the feasibility of using a simvastatin intervention, and to evaluate its effects on cancer progression, among 20 patients with platinum-sensitive ovarian cancer, treated with carboplatin and liposomal doxorubicin at Cedars-Sinai Medical Center.

Condition or disease Intervention/treatment Phase
Recurrent Ovarian Cancer Platinum-sensitive Ovarian Cancer Drug: Simvastatin 40mg Early Phase 1

Detailed Description:
This is a pilot study of statin therapy to examine the feasibility of simvastatin use to reduce disease progression in 20 patients with platinum-sensitive ovarian cancer at Cedars-Sinai Medical Center. This study will focus on patients with recurrent platinum sensitive ovarian cancer to increase the likelihood that this population will experience recurrent disease during the 6-month intervention and follow-up. In addition, this population of patients has a narrow range of standard of care carboplatin doublet combinations that are prescribed, enabling the investigators to create a more homogenous study population. Given their high risk of developing recurrent disease, women with platinum sensitive ovarian cancer, have the potential to derive the maximum benefit from an intervention that could delay disease progression and enhance survival.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
Experimental: Simvastatin Drug: Simvastatin 40mg
Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin
Other Name: Zocor




Primary Outcome Measures :
  1. Completion of the simvastatin intervention with at least 85% compliance [ Time Frame: From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days) ]
    Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.


Secondary Outcome Measures :
  1. Response by CA125 [ Time Frame: From baseline until 12 months ]
    Change in serum level of CA125

  2. Progression-free survival [ Time Frame: From baseline until 12 months ]
    Duration until disease progression or death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent platinum sensitive ovarian cancer, all histologies (serous, endometrioid, mucinous, clear cell). Platinum sensitivity defined as ≥ 6 months since last platinum treatment.
  • No contraindication to carboplatin and/or liposomal doxorubicin or simvastatin.

Exclusion Criteria:

  • Prior or current use of any statin medication
  • Current systemic use of medications known to interact with statins
  • Current use of any other investigational agents
  • Liver disease, active cirrhosis
  • Uncontrolled intercurrent illness
  • History of chronic myopathy
  • Prior cancer other than ovarian cancer or non-melanomatous skin cancers
  • Known active infection with HIV
  • Current excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day)
  • Prior exposure to doxorubicin or liposomal doxorubicin
  • Hemoglobin A1C >8.0%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457089


Contacts
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Contact: Cynthia Martin 310-423-2276 Cynthia.Martin@cshs.org

Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Contact: Cynthia Martin    310-423-2276    Cynthia.Martin@cshs.org   
Principal Investigator: Bobbie Jo Rimel, MD         
Sub-Investigator: Marc Goodman, PhD         
Sub-Investigator: Andrew Li, MD         
Sub-Investigator: Christine Walsh, MD         
Sub-Investigator: Kristin Taylor, MD         
Sponsors and Collaborators
Bobbie Jo Rimel, MD
Investigators
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Principal Investigator: Bobbie Jo Rimel, MD Cedars-Sinai Medical Center
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Responsible Party: Bobbie Jo Rimel, MD, Oncologist, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04457089    
Other Study ID Numbers: IIT2020-03-Rimel-STOV
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bobbie Jo Rimel, MD, Cedars-Sinai Medical Center:
simvastatin
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors