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ACTIVE NOT RECRUITING
NCT03949283
PHASE3

Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer

Sponsor: Cordgenics, LLC

View on ClinicalTrials.gov

Summary

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.

Official title: Standard Chemotherapy Versus Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2019-07-26

Completion Date

2024-12-30

Last Updated

2024-08-22

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

ChemoID Assay

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.

DRUG

Standard Chemotherapy

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.

Locations (8)

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