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Recurrent Ovarian CarcinomaPhase 3NCT03949283

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

A Phase 3 study testing ChemoID Assay and Standard Chemotherapy in people with Recurrent Ovarian Carcinoma and Platinum-resistant Ovarian Cancer, run by Cordgenics, LLC at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
ChemoID Assay and Standard Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
8 sitesUnited States
Study dates
26 Jul 2019to 30 Dec 2024
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent obtained and signed.
  • Participant is willing and able to commit to study procedures including long-term follow-up visit(s);
  • Participant must be a female and at least 18 years of age at the time of enrollment.
  • Negative pregnancy test for women of childbearing potential.
  • Participant has been diagnosed with recurrent platinum resistant epithelial ovarian, peritoneal, or fallopian tube carcinoma.
  • Participants must have an evaluable disease - defined as one of the following:
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  • 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:
  • ANC ≥ 1500/mm3
  • Hgb ≥ 10 mg/dl
  • Hct ≥ 28%
  • Platelet count ≥ 100,000/μL
  • Serum creatinine ≤ 2.0 mg/dl
  • Total bilirubin ≤ 2.5 mg/dl
  • AST/SGOT ≤ 3 times ULN. If intrahepatic liver metastases are present, AST and ALT must be ≤ 5 times institutional ULN.

Who cannot join

  • Use of Avastin planned to treat participant.
  • Participant has ovarian stromal, germ cell tumors or pure sarcomas.
  • Participant has borderline carcinoma (uncertain malignant potential), mutinous or low-grade serous carcinoma.
  • Participant is pregnant or lactating.
  • Participants of childbearing potential not employing adequate contraception.
  • 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.
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  • Estimated life expectancy of <6 months, as estimated by the investigator in consultation with participating oncologists.
  • Participants with symptomatic cardiac conditions (i.e. NYHA class III/IV or uncompensated angina).
  • Enrollment in another clinical study that precludes allowing the oncologist to select chemotherapy regimens.
  • Previously participated in this study.
  • 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).
  • CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease.
  • Patients with third space fluid (for example pleural effusions) as only site of disease.
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Charleston Area Medical Center (CAMC)

    Charleston, West Virginia, 25304

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45221

  • Edwards Comprehensive Cancer Center - Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Miami Cancer Institute/Baptist Health South Florida

    Miami, Florida, 33176

  • LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • West Penn Hospital, Allegheny Health Network

    Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: Standard Chemotherapy Versus Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer

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.

Read the 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.

Being tested
ChemoID Assay, Standard Chemotherapy
Keywords
Ovarian cancer, Platinum resistant, ChemoID, Cytotoxicity assay, Cancer Stem Cells
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemoID AssayDiagnostic test

    Also called Chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs)

    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.

  • Standard ChemotherapyDrug

    Also called 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.

Study groups in NCT03949283
Study groupRoleWhat they receive
Physician Choice TreatmentActive comparatorParticipants 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.
Receives: Diagnostic Test: ChemoID Assay; Drug: Standard Chemotherapy
ChemoID-guided treatmentExperimentalParticipants 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.
Receives: Diagnostic Test: ChemoID Assay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    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).

    Measured: 24 months

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    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.

    Measured: 24 months

  2. Duration of Response

    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.

    Measured: 24 months

  3. CA125 levels

    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.

    Measured: 24 months

  4. Health-Related Quality of Life (HRQOL)

    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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2019
  2. Study start26 Jul 2019
  3. Primary completion30 Jun 2024
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group randomized controlled clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03949283
Sponsor's protocol ID
CG03
Status last verified
Aug 2024
First submitted
11 May 2019
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Howard CM, Zgheib NB, Bush S 2nd, DeEulis T, Cortese A, Mollo A, Lirette ST, Denning K, Valluri J, Claudio PP. Clinical relevance of cancer stem cell chemotherapeutic assay for recurrent ovarian cancer. Transl Oncol. 2020 Dec;13(12):100860. doi: 10.1016/j.tranon.2020.100860. Epub 2020 Aug 28.

    PubMed 32862103

  • Howard CM, Bush S 2nd, Zgheib NB, Lirette ST, Cortese A, Mollo A, Valluri J, Claudio PP. Cancer Stem Cell Assay for the Treatment of Platinum-Resistant Recurrent Ovarian Cancer. HSOA J Stem Cells Res Dev Ther. 2021;7(3):076. doi: 10.24966/srdt-2060/100076. Epub 2021 Sep 9.

    PubMed 34796266

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ChemoID Assay and Standard Chemotherapy in people with Recurrent Ovarian Carcinoma and Platinum-resistant Ovarian Cancer, run by Cordgenics, LLC at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03949283, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.

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