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

Recurrent Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04457089
• Other study ID #: IIT2020-03-Rimel-STOV
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 25, 2021
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: Amy Oppenheim
• Phone: 310-423-2133
• Email: cancer.trial.info[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Hypersensitivity
• Ovarian Neoplasms
• Platinum-sensitive Ovarian Cancer
• Recurrent Ovarian Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Bobbie Jo Rimel, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days)
Secondary	Response by CA125	Change in serum level of CA125	From baseline until 12 months
Secondary	Progression-free survival	Duration until disease progression or death	From baseline until 12 months