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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bobbie Jo Rimel, MD
• Treatments: Simvastatin

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%