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Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Platinum-Resistant or -Sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT03632798•Cordgenics, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1\. Informed consent obtained and signed;
•2\. Willing and able to commit to study procedures including long-term follow-up visit(s);
•3\. At least 18 years old at the time of enrollment;
•4\. Negative pregnancy test for women of childbearing potential
•5\. Experiencing 1st, 2nd, or 3rd recurrent epithelial ovarian cancer of any stage regardless of platinum sensitivity, (platinum-sensitive, -resistant, or -refractory);
•6\. Histopathological or cytological confirmation of recurrent epithelial ovarian carcinoma, peritoneal cancer or fallopian tube cancer.
•7\. Evaluable disease - defined as RECIST 1.1 measurable disease OR not measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a CA125 \> 2x ULN).
•8\. At least 30 days post-cytotoxic chemotherapy and/or monoclonal antibody therapy prior to enrollment;
•9\. Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to Grade 1 as per CTCAE v4.0 (http://ctep.cancer.gov/protocol development/electronic\_applications/ctc.htm). Patients with long-standing stable grade 2 neuropathy may be considered after discussion with the Study Chair.
•10\. ECOG Performance Status Score of ≤ 2, KPS≥70, or 0-1 GOG status
+10 more criteria

Exclusion Criteria

•1\. Estimated life expectancy of \<6 months, as estimated by the investigator in consultation with participating oncologists;
•2\. Ovarian cancer of a low grade serous, mucinous, or clear cell histology;
•3\. Uncontrolled diabetes;
•4\. Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24-hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR ≤ 1.0 to allow participation in the study;
•5\. Symptomatic cardiac conditions;
•6\. Contraindications to bevacizumab including uncontrolled hypertension, known arterial or venous thromboembolism, known nephrotic syndrome, history of abdominal fistula, GIP, or intra-abdominal abscess; clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition; nonhealing wound, ulcer, or bone fracture; bleeding diathesis or significant coagulopathy; known CNS disease, clinically significant cardiovascular disease; and a major surgical procedure within 28 days of enrollment or anticipated to occur while participating in study;
•7\. Enrollment in another clinical study that precludes allowing the oncologist to select chemotherapy regimens;
•8\. Previously participated in this study;
•9\. Any condition that would, in the opinion of the investigator, place the participant at an unacceptable risk, or render the participant unable to meet the requirements of the protocol (including long-term study follow-up).
•10\. Documented history of ovarian cancer of a low malignant potential phenotype or unclear cell histology.
+2 more criteria

Locations (3)

Univeristy of Mississippi Medical Center

Jackson, Mississippi, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Edwards Comprehensive Cancer Center - Cabell Huntington Hospital

Huntington, West Virginia, United States

Key Dates

Start Date

August 1, 2018

Primary Completion Date

June 10, 2019

Completion Date

June 10, 2019

Last Updated

February 12, 2025

Conditions

Recurrent Ovarian Cancer

Interventions

ChemoID assay

DIAGNOSTIC_TEST

Chemotherapy

DRUG

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

NCT05942300

Recurrent Ovarian Cancer

View study

ACTIVE_NOT_RECRUITINGPHASE2

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

NCT05335993

Recurrent Ovarian CancerRecurrent Epithelial Cancer of Ovary+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

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