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Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer

NCT03632798 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-02-12

No results posted yet for this study

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.

Conditions

  • Recurrent Ovarian Cancer

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 not only bulk of tumor cells, but importantly the 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

Chemotherapy

Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent ovarian cancer. Chemotherapy list: * Liposomal Doxorubicin; * Docetaxel; * Paclitaxel; * Carboplatin; * Cisplatin; * Gemcitabine; * Topotecan; * Carboplatin, Gemcitabine; * Cisplatin, Gemcitabine; * Carboplatin, Liposomal Doxorubicin; * Carboplatin, Paclitaxel; * Carboplatin, Docetaxel.

Sponsors & Collaborators

  • Cordgenics, LLC

    lead INDUSTRY

Principal Investigators

  • Kelly J Wilkinson, MD · University of Mississippi Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-06-10
Completion
2019-06-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03632798 on ClinicalTrials.gov