Spots Global Cancer Trial Database for Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer

Study Description

Brief Summary: The purpose of this randomized clinical study is to confirm the utility of chemosensitivity (ChemoID) tumor testing on cancer stem cells as a predictor of clinical response in recurrent epithelial ovarian cancer (EOC), fallopian tube, or primary peritoneal cancer, regardless of platinum sensitivity. Population studied will be female participants experiencing a 1st, 2nd, or 3rd recurrence of any stage epithelial ovarian cancer.

Detailed Description: This study is designed as a parallel group randomized controlled clinical trial to determine if recurrent Epithelial Ovarian Cancer (EOC) patients treated with Bevacizumab plus drugs predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy (Bevacizumab plus chemotherapy chosen by the Physician). Upon obtaining informed consent, all eligible participants affected by 1st, 2nd, or 3rd relapse of EOC regardless of platinum sensitivity (both platinum sensitive and resistant) 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 (Bevacizumab plus chemotherapy chosen by the Physician from the provided list), or to a study arm of Bevacizumab plus 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 relapse number, platinum sensitivity, and study site to ensure balance within these cells.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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