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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
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.
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.
Kaiser Permanente
Los Angeles, California, United States
Miami Cancer Institute/Baptist Health South Florida
Miami, Florida, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
West Penn Hospital, Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center - Cabell Huntington Hospital
Huntington, West Virginia, United States
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).
Time frame: 24 months
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.
Time frame: 24 months
Duration of Response
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
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