Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer
NCT ID: NCT03949283
Last Updated: 2024-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2019-07-26
2024-12-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Cordgenics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Herzog, MD
Role: STUDY_CHAIR
University of Cincinnati
Locations
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Kaiser Permanente
Los Angeles, California, United States
Miami Cancer Institute/Baptist Health South Florida
Miami, Florida, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
West Penn Hospital, Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center - Cabell Huntington Hospital
Huntington, West Virginia, United States
Countries
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References
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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.
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.
Other Identifiers
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CG03
Identifier Type: -
Identifier Source: org_study_id
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