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

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ClinicalTrials.gov Identifier: NCT03949283
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Cordgenics, LLC

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Recurrent Ovarian Carcinoma Platinum-resistant Ovarian Cancer Diagnostic Test: ChemoID Assay Drug: Standard Chemotherapy Phase 3

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel group randomized controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study investigators will be kept blind to the schedule. All participants will be screened by the ChemoID drug response assay; however, the treating physician will receive the ChemoID results only for those participants who are randomized to receive ChemoID-guided treatment arm.
Primary Purpose: Treatment
Official Title: Standard Chemotherapy Versus Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer
Actual Study Start Date : July 26, 2019
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Physician Choice Treatment

Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the physician from the provided list).

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.
 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.

Other Name: Chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs)

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.

Other Name: Chemotherapy
Experimental: ChemoID-guided treatment

Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list.

ChemoID-guided treatment will be chosen from 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 receive the ChemoID assay results from the ChemoID lab.

 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.

Other Name: Chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs)


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 24 months ]
    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).


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 24 months ]
    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.

  2. Duration of Response [ Time Frame: 24 months ]
    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.

  3. CA125 levels [ Time Frame: 24 months ]
    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.

  4. Health-Related Quality of Life (HRQOL) [ Time Frame: 24 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Ovarian Cancer is a female disease
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent obtained and signed.
  2. Participant is willing and able to commit to study procedures including long-term follow-up visit(s);
  3. Participant must be a female and at least 18 years of age at the time of enrollment.
  4. Negative pregnancy test for women of childbearing potential.
  5. Participant has been diagnosed with recurrent platinum resistant epithelial ovarian, peritoneal, or fallopian tube carcinoma.
  6. Participants must have an evaluable disease - defined as one of the following:

1) RECIST 1.1 measurable disease (defined as one or more solid and/or cystic tumors on cross-sectional imaging that measures 1 cm or greater in long axis and/or lymph nodes measuring 1.5 cm or greater in short axis) 2) Evaluable disease (defined as solid and/or cystic tumors on radiographic imaging or physical exam that do not meet RECIST 1.1 definitions for target lesions) with elevated CA125 (GCIG recurrence and response criteria) by more than 2 times the upper limits of normal, confirmed in two successive samples, drawn at least one week apart).

7. Participant has agreed to provide a core biopsy of the primary site, a secondary metastatic site, or to undergo a paracentesis or thoracentesis for fluid collection.

8. An adequate fresh sample can be provided and submitted for ChemoID testing.

9. Participant has disease of one of the following histologic epithelial cell types: high-grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not otherwise specified (N.O.S.). Cytologic confirmation of diagnosis is acceptable for participants treated with neoadjuvant therapy who have not had a surgical procedure for a histologic confirmation. Patients with low-grade serous or mucinous adenocarcinoma are not eligible, nor are patients with pure ovarian sarcomas.

10. Participant has received ≤ 5 prior regimens including at least one platinum-based regimen for their ovarian, peritoneal, or fallopian tube carcinoma.

11. Participant must have an estimated life expectancy of greater than six months, as determined by the investigator.

12. Participant requires chemotherapy and the investigator plans to administer one of the regimens of interest as deemed by her physician.

13. Participant must have an ECOG Performance Status Score of ≤ 2, KPS≥70, or 0-2 GOG status.

14. Adequate laboratory values within 60 days of enrollment to study defined as follows:

  1. ANC ≥ 1500/mm3
  2. Hgb ≥ 10 mg/dl
  3. Hct ≥ 28%
  4. Platelet count ≥ 100,000/μL
  5. Serum creatinine ≤ 2.0 mg/dl
  6. Total bilirubin ≤ 2.5 mg/dl
  7. AST/SGOT ≤ 3 times ULN. If intrahepatic liver metastases are present, AST and ALT must be ≤ 5 times institutional ULN.

Exclusion Criteria:

  1. Use of Avastin planned to treat participant.
  2. Participant has ovarian stromal, germ cell tumors or pure sarcomas.
  3. Participant has borderline carcinoma (uncertain malignant potential), mutinous or low-grade serous carcinoma.
  4. Participant is pregnant or lactating.
  5. Participants of childbearing potential not employing adequate contraception.
  6. Participants who are at risk of failure of compliance to the visit schedules and procedures including those with psychiatric disease that would substantially impact compliance or consent.
  7. Estimated life expectancy of <6 months, as estimated by the investigator in consultation with participating oncologists.
  8. Participants with symptomatic cardiac conditions (i.e. NYHA class III/IV or uncompensated angina).
  9. Enrollment in another clinical study that precludes allowing the oncologist to select chemotherapy regimens.
  10. Previously participated in this study.
  11. 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).
  12. CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease.
  13. Patients with third space fluid (for example pleural effusions) as only site of disease.
  14. Participant may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949283


Contacts
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Contact: Thomas J Herzog, MD (513)558-2177 HERZOGTJ@ucmail.uc.edu

Locations
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United States, Arizona
Arizona Oncology Withdrawn
Phoenix, Arizona, United States, 85102
United States, California
Kaiser Permanente Recruiting
Los Angeles, California, United States, 90027
Contact: Scott Lentz, MD    323-783-4011    Scott.E.Lentz@kp.org   
Contact: Sandra Baker-Bolden    323-783-5532    Sandra.t.baker@kp.org   
United States, Florida
Miami Cancer Institute/Baptist Health South Florida Recruiting
Miami, Florida, United States, 33176
Contact: Xiaoou Pan    786-527-8861    Xiaoou.pan@BaptistHealth.net   
Contact: Maliha Alam, MPH    786-527-8862    Maliha.Alam@baptisthealth.net   
Principal Investigator: John P Diaz, MD         
United States, Indiana
Indiana University Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kathryn M Sanders, BS    317-278-2351    kmb9@iu.edu   
Principal Investigator: Lisa Landrum, MD         
United States, Louisiana
LSU Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Navya Nair, MD, MPH    504-412-1650    nnair@lsuhsc.edu   
Contact: Muriel Roberts, BSN, RN    504-210-1847    Mcar14@lsuhsc.edu   
United States, Ohio
University of Cincinnati Cancer Institute Recruiting
Cincinnati, Ohio, United States, 45221
Contact: Thomas J Herzog, MD    513-584-6373    HERZOGTJ@ucmail.uc.edu   
Contact: Laura Bundus, CRC    513-584-7847    bundusla@ucmail.edu   
Principal Investigator: Thomas J Herzog, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Stephanie Robbins, BS    405-271-8001 ext 31453    robbins@ouhsc.edu   
Principal Investigator: Laura Holman, MD         
United States, Pennsylvania
West Penn Hospital, Allegheny Health Network Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Thomas Krivak, MD    412-578-1116    Thomas.Krivak@ahn.org   
Contact: Erin Baldauf, Med, CCRC    412-578-4517    Erin.Baldauf@ahn.org   
Principal Investigator: Thomas Krivak, MD         
United States, West Virginia
Charleston Area Medical Center (CAMC) Recruiting
Charleston, West Virginia, United States, 25304
Contact: Stephen Bush II, MD       Stephen.H.Bush@camc.org   
Contact: Augusta Kosowicz, CCRC    304-388-9940    augusta.kosowicz@camc.org   
Principal Investigator: Stephen Bush, MD         
Edwards Comprehensive Cancer Center - Cabell Huntington Hospital Recruiting
Huntington, West Virginia, United States, 25701
Contact: Nadim Bou Zgheib, MD    304-399-6600    zgheib@marshall.edu   
Contact: Keshia Bowen, RN    304-399-6521    keshia.bowen@chhi.org   
Principal Investigator: Nadim Bou Zgheib, MD         
Sponsors and Collaborators
Cordgenics, LLC
Investigators
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Study Chair: Thomas Herzog, MD University of Cincinnati
More Information
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Publications:

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Responsible Party: Cordgenics, LLC
ClinicalTrials.gov Identifier: NCT03949283    
Other Study ID Numbers: CG03
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cordgenics, LLC:
Ovarian cancer
Platinum resistant
ChemoID
Cytotoxicity assay
Cancer Stem Cells
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Recurrence
Disease Attributes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type