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The purpose of this clinical study is to confirm the utility of chemosensitivity (ChemoID) tumor testing on cancer stem cells as a predictor of clinical response in recurrent platinum resistant epithelial ovarian cancer (EOC), fallopian tube, or primary peritoneal cancer.
Population studied will be female participants experiencing a recurrent platinum-resistant ovarian cancer (no mucinous, low grade serous, or pure sarcoma types), with ≤ 5 prior treatments, and a performance status 0-1.
This study is designed as a parallel group randomized controlled clinical trial to determine if recurrent platinum resistant epithelial ovarian cancer (EOC) patients treated with chemotherapy predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy chosen by the physician.
Upon obtaining informed consent, all eligible participants affected by recurrent platinum-resistant ovarian cancer (no mucinous, low grade serous, or pure sarcoma types), with ≤ 5 prior treatments, and a performance status 0-1 will have a tumor biopsy or a cancer-positive fluid collection sample to undergo ChemoID drug response testing with multiple FDA-approved chemotherapeutic agents.
Eligible participants will be randomized to a standard treatment arm with control treatment (chemotherapy chosen by the Physician from a provided list), or to a study arm of FDA-approved drugs selected by the ChemoID drug response assay.
A stratified randomization approach for treatment arm assignment will be used with strata based on number of prior platinum treatments and BRCA status to ensure balance within these cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician Choice Treatment | Active Comparator | Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the physician from the provided list). Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations:
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| ChemoID-guided treatment | Experimental | Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list. ChemoID-guided treatment will be chosen from the following standard-of-care chemotherapy drugs or combinations:
The treating physician will receive the ChemoID assay results from the ChemoID lab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChemoID Assay | Diagnostic Test | The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses patient's live tumor cells to indicate which chemotherapy agent (or combinations) will kill bulk of tumor cells, and cancer stem cells (CSCs) that are known to cause cancer to recur. During the assay, cancer stem cells and bulk tumor cells from an individual patient are exposed to FDA-approved chemotherapy drugs. The test measures the cytotoxic effect of actual doses of standard-of-care chemotherapies. The ChemoID drug response assay reports a prioritized list of effective and ineffective chemotherapies. The test is designed to target cancer stem cells to mitigate tumor relapse. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective response rate (ORR) as measured by RECIST version 1.1 criteria in recurrent EOC patients who have had ChemoID-guided treatment versus physician choice control treatment (chemotherapy chosen by the physician from the provided list). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression free survival (PFS) in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (chemotherapy chosen by the physician from the provided list) versus ChemoID drug response assay-directed chemotherapy. | 24 months |
| Duration of Response |
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Inclusion Criteria:
1) RECIST 1.1 measurable disease (defined as one or more solid and/or cystic tumors on cross-sectional imaging that measures 1 cm or greater in long axis and/or lymph nodes measuring 1.5 cm or greater in short axis) 2) Evaluable disease (defined as solid and/or cystic tumors on radiographic imaging or physical exam that do not meet RECIST 1.1 definitions for target lesions) with elevated CA125 (GCIG recurrence and response criteria) by more than 2 times the upper limits of normal, confirmed in two successive samples, drawn at least one week apart).
7. Participant has agreed to provide a core biopsy of the primary site, a secondary metastatic site, or to undergo a paracentesis or thoracentesis for fluid collection.
8. An adequate fresh sample can be provided and submitted for ChemoID testing.
9. Participant has disease of one of the following histologic epithelial cell types: high-grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not otherwise specified (N.O.S.). Cytologic confirmation of diagnosis is acceptable for participants treated with neoadjuvant therapy who have not had a surgical procedure for a histologic confirmation. Patients with low-grade serous or mucinous adenocarcinoma are not eligible, nor are patients with pure ovarian sarcomas.
10. Participant has received ≤ 5 prior regimens including at least one platinum-based regimen for their ovarian, peritoneal, or fallopian tube carcinoma.
11. Participant must have an estimated life expectancy of greater than six months, as determined by the investigator.
12. Participant requires chemotherapy and the investigator plans to administer one of the regimens of interest as deemed by her physician.
13. Participant must have an ECOG Performance Status Score of ≤ 2, KPS≥70, or 0-2 GOG status.
14. Adequate laboratory values within 60 days of enrollment to study defined as follows:
Exclusion Criteria:
Ovarian Cancer is a female disease
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Herzog, MD | University of Cincinnati | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | Los Angeles | California | 90027 | United States | ||
| Miami Cancer Institute/Baptist Health South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32862103 | Background | Howard CM, Zgheib NB, Bush S 2nd, DeEulis T, Cortese A, Mollo A, Lirette ST, Denning K, Valluri J, Claudio PP. Clinical relevance of cancer stem cell chemotherapeutic assay for recurrent ovarian cancer. Transl Oncol. 2020 Dec;13(12):100860. doi: 10.1016/j.tranon.2020.100860. Epub 2020 Aug 28. | |
| 34796266 | Background |
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Parallel group randomized controlled clinical trial
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Study investigators will be kept blind to the schedule. All participants will be screened by the ChemoID drug response assay; however, the treating physician will receive the ChemoID results only for those participants who are randomized to receive ChemoID-guided treatment arm.
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| Standard Chemotherapy | Drug | Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations: Liposomal Doxorubicin; Docetaxel; Paclitaxel; Carboplatin; Cisplatin; Gemcitabine; Topotecan; Carboplatin, Gemcitabine; Cisplatin, Gemcitabine; Carboplatin, Liposomal Doxorubicin; Carboplatin, Paclitaxel; Carboplatin, Docetaxel. The treating physician will NOT receive the ChemoID assay results from the ChemoID lab. |
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Duration of Response (DOR) in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (chemotherapy chosen by the physician from the provided list) versus ChemoID drug response assay-directed chemotherapy. |
| 24 months |
| CA125 levels | Levels of CA125 in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (chemotherapy chosen by the physician from the provided list) versus ChemoID drug response assay-directed chemotherapy. | 24 months |
| Health-Related Quality of Life (HRQOL) | Health-Related Quality of Life (HRQOL) measured to ChemoID-guided treatment selection vs. standard chemotherapy chosen by the physician using self-reported and validated questionnaires, addressing physical, psychological, emotional, and social issues. | 24 months |
| Miami |
| Florida |
| 33176 |
| United States |
| LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | 45221 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| West Penn Hospital, Allegheny Health Network | Pittsburgh | Pennsylvania | 15224 | United States |
| Charleston Area Medical Center (CAMC) | Charleston | West Virginia | 25304 | United States |
| Edwards Comprehensive Cancer Center - Cabell Huntington Hospital | Huntington | West Virginia | 25701 | United States |
| Howard CM, Bush S 2nd, Zgheib NB, Lirette ST, Cortese A, Mollo A, Valluri J, Claudio PP. Cancer Stem Cell Assay for the Treatment of Platinum-Resistant Recurrent Ovarian Cancer. HSOA J Stem Cells Res Dev Ther. 2021;7(3):076. doi: 10.24966/srdt-2060/100076. Epub 2021 Sep 9. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 11, 2025 | Mar 3, 2025 | 16 | ||
| Apr 1, 2025 | Apr 17, 2025 | 17 | ||
| May 27, 2025 | May 28, 2025 | 18 | ||
| May 28, 2025 | May 29, 2025 | 19 | ||
| May 29, 2025 | May 30, 2025 | 20 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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