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| ID | Type | Description | Link |
|---|---|---|---|
| E01775.1a | Other Grant/Funding Number | DOD |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Sharp | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Randomized to Aspirin | Experimental | Participants randomized to this arm will receive 325mg daily dose aspirin |
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| Participants Randomized to Placebo | Placebo Comparator | Participants randomized to this arm will receive a daily dose of a placebo (inactive substance) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 325mg | Drug | Participants will receive a tablet of 325mg aspirin that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells from diagnostic biopsy to interval debulking surgery | Change in intratumoral density of immunosuppressive T-regulatory (FOXP3+) cells will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)*100 / density in the biopsy tissue sample. | Up to 5 months |
| Change in intratumoral density of M2 tumor-associated macrophages (CD163+ cells) from diagnostic biopsy to interval debulking surgery | Change in intratumoral density of of M2 tumor-associated macrophages (CD163+ cells) will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)*100 / density in the biopsy tissue sample. | Up to 5 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in density of tumor COX1 | Change in density of tumor COX1 will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)*100 / density in the biopsy tissue sample. | Up to 5 Months |
| Change in density of tumor COX2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Shiles | Contact | 813-745-2948 | Tiffany.Shiles@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Jing-Yi Chern, MD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo | Drug | Participants will receive a placebo tablet that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery. |
|
Change in density of tumor COX2 will be measured by using this formula: (density in the debulking surgery tissue sample - density in the biopsy tissue sample)*100 / density in the biopsy tissue sample. |
| Up to 5 Months |
| Change in blood levels of IL-6 | Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4 | Up to 84 days |
| Change in blood levels of p-selectin | Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4 | Up to 84 days |
| Change in blood levels of CA 125 | Investigators will calculate the percent change in the concentration of the biomarker from baseline to Visit 4 | Up to 84 days |
| Change in tumor burden as defined by RECIST 1.1 | Change in tumor burden be assessed using Response Evaluation Criteria in Solid Tumors guideline version 1.1 (RECIST 1.1) | Up to 5 Months |
| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| University of Virginia Comprehensive Cancer Center | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| Inova Schar Cancer Institute | Recruiting | Fairfax | Virginia | 22031 | United States |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |