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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 : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Cordgenics, LLC

Tracking Information
First Submitted Date  ICMJE May 11, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date October 15, 2019
Actual Study Start Date  ICMJE July 26, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03949283 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer
Official Title  ICMJE Standard Chemotherapy Versus Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Recurrent Ovarian Carcinoma
  • Platinum-resistant Ovarian Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Diagnostic Test: ChemoID Assay
    • Drug: Standard 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.

    Intervention: Diagnostic Test: ChemoID Assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2019)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Participant must have measurable disease by RECIST 1.1 or objective physical parameter.
  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 to be 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 platinum-based regimens for their ovarian, peritoneal, or fallopian tube carcinoma.
  11. Participant must have completed prior chemotherapy regimens at least 4 weeks prior to tissue extraction.
  12. Participant must have an estimated life expectancy of greater than six months, as determined by the investigator.
  13. Participant requires chemotherapy and the investigator plans to administer one of the regimens of interest as deemed by her physician.
  14. Participant must have an ECOG Performance Status Score of ≤ 2, KPS≥70, or 0-1 GOG status.
  15. At least 30 days post-cytotoxic chemotherapy and/or monoclonal antibody therapy prior to enrollment;
  16. Adequate laboratory values within 60 days of enrollment to study defined as follows:

    1. WBC ≥ 3000/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.
    8. Random urine protein/creatinine ratio ≤ 1 or 24 hour urine protein < 0.1 gram.

Exclusion Criteria:

  1. Use of Avastin planned to treat participant.
  2. Participant has ovarian stromal or germ cell tumors.
  3. Participant has borderline carcinoma (uncertain malignant potential).
  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. Uncontrolled diabetes.
  9. Participants with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); Participant must have a UPCR ≤ 1.0 to allow participation in the study.
  10. Participants with symptomatic cardiac conditions (i.e. NYHA class III/IV or uncompensated angina).
  11. Enrollment in another clinical study that precludes allowing the oncologist to select chemotherapy regimens.
  12. Previously participated in this study.
  13. 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).
  14. CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease.
  15. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Ovarian Cancer is a female disease
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas J Herzog, MD (513)558-2177 HERZOGTJ@ucmail.uc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949283
Other Study ID Numbers  ICMJE CG03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cordgenics, LLC
Study Sponsor  ICMJE Cordgenics, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Thomas Herzog, MD University of Cincinnati
PRS Account Cordgenics, LLC
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP