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

Primary Purpose

Recurrent Ovarian Cancer, Platinum-sensitive Ovarian Cancer

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Simvastatin 40mg

About this trial

This is an interventional treatment trial for Recurrent Ovarian Cancer focused on measuring simvastatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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%

Sites / Locations

Cedars Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Simvastatin

Arm Description

Outcomes

Primary Outcome Measures

Completion of the simvastatin intervention with at least 85% compliance

Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.

Secondary Outcome Measures

Response by CA125

Change in serum level of CA125

Progression-free survival

Duration until disease progression or death

Full Information

NCT ID

NCT04457089

First Posted

June 25, 2020

Last Updated

October 2, 2023

Sponsor

Bobbie Jo Rimel, MD

1. Study Identification

Unique Protocol Identification Number

NCT04457089

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 25, 2021 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bobbie Jo Rimel, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Ovarian Cancer, Platinum-sensitive Ovarian Cancer

Keywords

simvastatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Simvastatin 40mg

Other Intervention Name(s)

Zocor

Intervention Description

Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin

Primary Outcome Measure Information:

Title

Completion of the simvastatin intervention with at least 85% compliance

Description

Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.

Time Frame

From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days)

Secondary Outcome Measure Information:

Title

Response by CA125

Description

Change in serum level of CA125

Time Frame

From baseline until 12 months

Title

Progression-free survival

Description

Duration until disease progression or death

Time Frame

From baseline until 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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%

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy Oppenheim

Phone

310-423-2133

cancer.trial.info@cshs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bobbie Jo Rimel, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cynthia Martin

Phone

310-423-2276

Cynthia.Martin@cshs.org

First Name & Middle Initial & Last Name & Degree

Bobbie Jo Rimel, MD

First Name & Middle Initial & Last Name & Degree

Marc Goodman, PhD

First Name & Middle Initial & Last Name & Degree

Andrew Li, MD

First Name & Middle Initial & Last Name & Degree

Christine Walsh, MD

First Name & Middle Initial & Last Name & Degree

Kristin Taylor, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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