Statin Therapy for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Bobbie Jo Rimel, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Bobbie Jo Rimel, MD

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications?

The trial requires that you do not use any statin medications or medications that interact with statins. If you are on such medications, you will need to stop them to participate.

What data supports the idea that Statin Therapy for Ovarian Cancer (also known as: Simvastatin, Zocor, Simvastatin) is an effective treatment?

The available research shows that simvastatin, a drug used in statin therapy, has promising effects in treating ovarian cancer. In studies, simvastatin was found to significantly slow down the growth of ovarian cancer cells and even cause them to die. It also reduced the ability of cancer cells to spread and stick to other areas. In experiments with mice, simvastatin treatment led to smaller tumor sizes and longer survival times. Additionally, in ovarian clear cell carcinoma, simvastatin reduced cell growth by about 40% to 50% and helped mice live longer. These findings suggest that simvastatin could be a beneficial treatment for ovarian cancer and deserves more research in clinical trials. ^{1 2 3 4 5}

What safety data exists for using statins in ovarian cancer treatment?

The review titled 'Statin as Repurposed Drug in Ovarian Cancer: A Comprehensive Review' suggests that statins, such as Simvastatin, have potential antitumor effects and could be repurposed for ovarian cancer treatment. The review discusses the pharmacotherapeutic potential of statins and highlights studies examining their impact on risk reduction and survival in ovarian cancer patients. It also mentions the use of nanotechnology to improve the drug's bioavailability and targeted delivery, which could enhance safety and efficacy. However, specific safety data for statins in ovarian cancer treatment is not detailed in the provided abstracts. ^{6 7 8 9 10}

Is the drug used in the trial 'Statin Therapy for Ovarian Cancer' a promising treatment?

Yes, the drug simvastatin shows promise as a treatment for ovarian cancer. It has been found to slow down cancer cell growth, cause cancer cells to die, and reduce tumor size in studies. This suggests it could be beneficial in treating ovarian cancer. ^{1 2 5 11 12}

Research Team

Bobbie Jo Rimel, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for women with recurrent ovarian cancer that responds to platinum-based chemotherapy, provided they haven't used statins or drugs that interact with them, have no liver disease or uncontrolled illnesses, and don't consume excessive alcohol.

Inclusion Criteria

My ovarian cancer has returned but responds to platinum treatment.

I am not allergic or unable to take carboplatin, liposomal doxorubicin, or simvastatin.

Exclusion Criteria

You drink more than 5 alcoholic drinks every day.

Current use of any other investigational agents

I do not have any unmanaged ongoing illnesses.

Treatment Details

Interventions

• Simvastatin (HMG-CoA Reductase Inhibitor)

Trial Overview The study tests the use of Simvastatin 40mg in combination with carboplatin and liposomal doxorubicin on 20 patients at Cedars-Sinai Medical Center to see if it slows down cancer progression in those with platinum-sensitive ovarian cancer.

Participant Groups

Group I: Simvastatin Experimental Treatment 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cedars Sinai Medical Center Los Angeles, CA

Who Is Running the Clinical Trial?

Bobbie Jo Rimel, MD

Lead Sponsor

Trials

1

Patients Recruited

20+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HMG-CoA reductase inhibitor, simvastatin, exhibits anti-metastatic and anti-tumorigenic effects in ovarian cancer. Stine, JE., Guo, H., Sheng, X., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statin-mediated reduction of osteopontin expression induces apoptosis and cell growth arrest in ovarian clear cell carcinoma. Matsuura, M., Suzuki, T., Suzuki, M., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single Arm, Phase II Study of Simvastatin Plus XELOX and Bevacizumab as First-Line Chemotherapy in Metastatic Colorectal Cancer Patients. Kim, Y., Kim, TW., Han, SW., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statin therapy is associated with improved survival in patients with non-serous-papillary epithelial ovarian cancer: a retrospective cohort analysis. Habis, M., Wroblewski, K., Bradaric, M., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluvastatin and cisplatin demonstrate synergistic cytotoxicity in epithelial ovarian cancer cells. Taylor-Harding, B., Orsulic, S., Karlan, BY., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statin as Repurposed Drug in Ovarian Cancer: A Comprehensive Review. Ahmad, A., Javed, S., Kiran, S.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic Effects of Simvastatin and Irinotecan against Colon Cancer Cells with or without Irinotecan Resistance. Jang, HJ., Hong, EM., Jang, J., et al.[2020]

Polymeric nanoparticles made from Ecoflex® were successfully developed to deliver docetaxel (DTX) for ovarian cancer treatment, showing improved drug uptake and reduced side effects compared to free DTX.

In vivo studies on tumor-bearing mice demonstrated that DTX-loaded nanoparticles significantly enhanced anti-tumor efficacy, suggesting they could be a promising alternative to existing DTX formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poly (butylene adipate-co-butylene terephthalate) nanoparticles prepared by electrospraying technique for docetaxel delivery in ovarian cancer induced mice. Varshosaz, J., Ghassami, E., Noorbakhsh, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative therapies for advanced ovarian cancer. Trimble, EL.[2012]

Ovarian cancer is a leading cause of gynecological cancer deaths, with a low 5-year survival rate of 45%, highlighting the urgent need for new treatment options.

The presence of T cells in ovarian cancer tumors is linked to better survival outcomes, suggesting that immunotherapy, including cancer vaccines and adoptive T-cell therapy, could be a promising approach to improve treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunities in immunotherapy of ovarian cancer. Coukos, G., Tanyi, J., Kandalaft, LE.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mutant p53 murine oviductal epithelial cells induce progression of high-grade serous carcinoma and are most sensitive to simvastatin therapy in vitro and in vivo. Pereira, M., Glogova, A., Haagsma, J., et al.[2023]

In a retrospective study of 60 patients with advanced-stage ovarian cancer, statin use did not show any significant improvement in overall survival compared to those not using statins (P = 0.966).

The presence of residual tumor after treatment was significantly associated with better overall survival, indicating that tumor status is a more critical factor in patient outcomes than statin use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statin as a Combined Therapy for Advanced-Stage Ovarian Cancer: A Propensity Score Matched Analysis. Chen, HY., Wang, Q., Xu, QH., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

The HMG-CoA reductase inhibitor, simvastatin, exhibits anti-metastatic and anti-tumorigenic effects in ovarian cancer. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Statin-mediated reduction of osteopontin expression induces apoptosis and cell growth arrest in ovarian clear cell carcinoma. [2013]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

A Single Arm, Phase II Study of Simvastatin Plus XELOX and Bevacizumab as First-Line Chemotherapy in Metastatic Colorectal Cancer Patients. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Statin therapy is associated with improved survival in patients with non-serous-papillary epithelial ovarian cancer: a retrospective cohort analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Fluvastatin and cisplatin demonstrate synergistic cytotoxicity in epithelial ovarian cancer cells. [2018]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Statin as Repurposed Drug in Ovarian Cancer: A Comprehensive Review. [2023]

7. Egypt pubmed.ncbi.nlm.nih.gov

Synergistic Effects of Simvastatin and Irinotecan against Colon Cancer Cells with or without Irinotecan Resistance. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Poly (butylene adipate-co-butylene terephthalate) nanoparticles prepared by electrospraying technique for docetaxel delivery in ovarian cancer induced mice. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Innovative therapies for advanced ovarian cancer. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Opportunities in immunotherapy of ovarian cancer. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Mutant p53 murine oviductal epithelial cells induce progression of high-grade serous carcinoma and are most sensitive to simvastatin therapy in vitro and in vivo. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Statin as a Combined Therapy for Advanced-Stage Ovarian Cancer: A Propensity Score Matched Analysis. [2018]