Aspirin for Ovarian Cancer

Recruiting at 3 trial locations

Overseen By Tiffany Shiles

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must be taking: Neoadjuvant chemotherapy

Must not be taking: Chronic steroids, NSAIDs

Disqualifiers: Vascular events, Uncontrolled HTN, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using anti-coagulation medication, you may need to temporarily stop based on your doctor's judgment.

What data supports the effectiveness of the drug aspirin for ovarian cancer?

Research suggests that aspirin use is linked to longer survival in women with clear cell ovarian cancer, with aspirin users showing improved disease-free and overall survival compared to non-users. Additionally, aspirin has shown potential in reducing ovarian cancer growth in preclinical models, especially when combined with other treatments. ^{1 2 3 4 5}

Is aspirin generally safe for humans?

Aspirin, also known as acetylsalicylic acid, is widely used and generally considered safe for many people, but it can have side effects like stomach upset or bleeding, especially with long-term use. It is important to consult with a healthcare provider before starting aspirin, especially for cancer prevention or treatment, to ensure it is safe for your specific health situation. ^{1 3 5 6 7}

How does aspirin differ from other drugs for ovarian cancer?

Aspirin is unique in its potential to improve survival in ovarian cancer patients by inhibiting COX-1, an enzyme often overexpressed in these cancer cells, and possibly affecting other pathways involved in tumor progression. Unlike standard chemotherapy, aspirin is a common anti-inflammatory drug that may offer additional benefits in reducing cancer cell growth and improving survival outcomes. ^{1 3 4 5 8}

Research Team

Jing-Yi Chern

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for women aged 18+ with ovarian, fallopian tube, or peritoneal carcinoma who haven't started treatment. They must be able to read English/Spanish (U.S.) or English/French (Canada), have a certain disease severity and type, plan to undergo specific chemotherapy followed by surgery, and meet health criteria like blood counts and organ function.

Inclusion Criteria

My liver function tests are within acceptable limits.

I am 18 years old or older.

My kidneys work well enough, based on a creatinine clearance test.

Exclusion Criteria

I cannot swallow pills and have stomach issues that could affect medication absorption.

I have not been diagnosed with any cancer other than non-melanoma skin cancer in the last 3 years.

I have severe esophagitis that hasn't improved with two treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive aspirin or placebo with neoadjuvant chemotherapy

12 weeks

4 visits (in-person)

Interval Debulking Surgery

Participants undergo interval debulking surgery to assess changes in tumor markers

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Aspirin
• Placebo

Trial Overview The study tests if aspirin can boost the immune system's response to tumors when given with standard chemo before surgery in patients with certain types of female reproductive cancers. Participants will either receive aspirin or a placebo alongside their chemotherapy regimen.

Participant Groups

Group I: Participants Randomized to Aspirin Experimental Treatment 1 Intervention

Participants randomized to this arm will receive 325mg daily dose aspirin

Group II: Participants Randomized to Placebo Placebo Group 1 Intervention

Participants randomized to this arm will receive a daily dose of a placebo (inactive substance)

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Sharp

Industry Sponsor

Trials

4

Recruited

450+

Sharp Clinical Services, Inc

Collaborator

Trials

1

Recruited

100+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

In a study of 4,117 women with epithelial ovarian cancer, postdiagnosis use of low-dose aspirin showed no significant reduction in ovarian cancer-specific mortality, with a hazard ratio of 1.02.

The findings suggest that low-dose aspirin does not improve survival rates for ovarian cancer patients, as the hazard ratios remained neutral regardless of aspirin use patterns or other mortality predictors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin use and ovarian cancer mortality in a Danish nationwide cohort study. Verdoodt, F., Kjaer, SK., Dehlendorff, C., et al.[2019]

Aspirin-PC, a novel form of aspirin, was found to be significantly more effective than regular aspirin in inhibiting the growth of ovarian cancer cells in both human and mouse models, reducing tumor growth by 50% to 90%.

The combination of aspirin-PC with VEGF inhibitors like Bevacizumab enhanced its efficacy, while both aspirin formulations showed no gastrointestinal toxicity, making aspirin-PC a safer alternative for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor and Antiangiogenic Effects of Aspirin-PC in Ovarian Cancer. Huang, Y., Lichtenberger, LM., Taylor, M., et al.[2020]

Aspirin (ASA) significantly inhibits the activity of myeloperoxidase (MPO), an enzyme elevated in women with ovarian cancer, with a concentration of 50 mM leading to over 90% inhibition.

This study suggests that aspirin may have a beneficial role in cancer treatment by affecting MPO activity, which could contribute to its potential survival benefits in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Acetylsalicylic Acid, as a Representative Non-Steroidal Anti-Inflammatory Drug, on the Activity of Myeloperoxidase. Gąsowska-Bajger, B., Sosnowska, K., Gąsowska-Bodnar, A., et al.[2023]

In a study of 77 patients with clear cell ovarian cancer, those who used aspirin showed significantly improved disease-free survival and overall survival compared to non-users, with a hazard ratio of 0.13 indicating a strong protective effect.

Aspirin use remained a significant positive prognostic factor even after adjusting for age, cancer stage, and treatment status, suggesting its potential role in enhancing survival outcomes in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin use correlates with survival in women with clear cell ovarian cancer. Wield, AM., Walsh, CS., Rimel, BJ., et al.[2020]

A nationwide case-control study involving 4,103 ovarian cancer cases and 58,706 controls found that low-dose aspirin use is associated with a reduced risk of epithelial ovarian cancer, with an odds ratio of 0.94 for ever use.

Long-term use of low-dose aspirin (≥5 years) showed an even greater reduction in risk (OR = 0.77), and continuous long-term use was linked to a significant decrease in risk (OR = 0.56), particularly for mucinous and endometrioid tumor types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose aspirin use and the risk of ovarian cancer in Denmark. Baandrup, L., Kjaer, SK., Olsen, JH., et al.[2022]

Observational studies suggest that long-term consistent use of aspirin may modestly reduce the risk of ovarian and endometrial cancer, particularly in certain subgroups like individuals with a high body mass index.

The evidence for non-aspirin NSAIDs is less clear, and there is a need for more research to better understand the impact of both aspirin and non-aspirin NSAIDs on cancer risk and prognosis, especially regarding factors like dosage and duration of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of aspirin and non-aspirin NSAID use on ovarian and endometrial cancer: Summary of epidemiologic evidence of cancer risk and prognosis. Verdoodt, F., Kjaer, SK., Friis, S.[2018]

Aspirin not only reduces inflammation by blocking COX-2 in platelets but also has a direct antitumor effect on intestinal cells, potentially preventing cancer development, as shown in randomized trials involving patients with colorectal neoplasia and Lynch syndrome.

Aspirin is effective in reducing the risk of cancer recurrence and metastasis, with ongoing studies exploring its long-term anticancer benefits, while also being established as a treatment for antiphospholipid syndrome and for cardiovascular disease prevention in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin in the 21st century-common mechanisms of disease and their modulation by aspirin: a report from the 2015 scientific conference of the international aspirin foundation, 28 August, London, UK. Smith, T., Hutchison, P., Schrör, K., et al.[2021]

Aspirin effectively reduces the growth of ovarian cancer cells that express high levels of COX-1, demonstrating a dose-dependent inhibition of cell viability when stimulated by EGF.

The mechanism of action involves aspirin blocking the phosphorylation of key proteins (Akt and Erk) that promote cell proliferation, suggesting that aspirin could enhance the effectiveness of treatments for COX-1 positive ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin Blocks EGF-stimulated Cell Viability in a COX-1 Dependent Manner in Ovarian Cancer Cells. Cho, M., Kabir, SM., Dong, Y., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Aspirin use and ovarian cancer mortality in a Danish nationwide cohort study. [2019]

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

Antitumor and Antiangiogenic Effects of Aspirin-PC in Ovarian Cancer. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Acetylsalicylic Acid, as a Representative Non-Steroidal Anti-Inflammatory Drug, on the Activity of Myeloperoxidase. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Aspirin use correlates with survival in women with clear cell ovarian cancer. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Low-dose aspirin use and the risk of ovarian cancer in Denmark. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Influence of aspirin and non-aspirin NSAID use on ovarian and endometrial cancer: Summary of epidemiologic evidence of cancer risk and prognosis. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Aspirin in the 21st century-common mechanisms of disease and their modulation by aspirin: a report from the 2015 scientific conference of the international aspirin foundation, 28 August, London, UK. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Aspirin Blocks EGF-stimulated Cell Viability in a COX-1 Dependent Manner in Ovarian Cancer Cells. [2021]