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 |
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Recurrent Ovarian Carcinoma Platinum-resistant Ovarian Cancer | Diagnostic Test: ChemoID Assay Drug: Standard Chemotherapy | Phase 3 |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 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, 2021 |
Estimated Study Completion Date : | December 30, 2021 |
Arm | Intervention/treatment |
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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:
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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
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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:
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)
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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 |
Inclusion Criteria:
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:
Exclusion Criteria:
Contact: Thomas J Herzog, MD | (513)558-2177 | HERZOGTJ@ucmail.uc.edu |
United States, Arizona | |
Arizona Oncology | Recruiting |
Phoenix, Arizona, United States, 85102 | |
Contact: Bradley Monk, MD 888-972-2873 Bradley.Monk@usoncology.com | |
Contact: Aarthi Raman 408-276-5119 Aarthi.Raman@usoncology.com | |
Principal Investigator: Bradley Monk, MD | |
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: Jetsenea Coto, CCRC 768-594-7636 JetseneaC@baptisthealth.net | |
Principal Investigator: John P Diaz, MD, FACOG | |
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: Paul Mayor, MD | |
United States, Louisiana | |
LSU Health Sciences Center | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Navya Nair, MD, MPH, FACOG 504-412-1650 nnair@lsuhsc.edu | |
Contact: Muriel Roberts, BSN, RN, CCRC 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: Camille Gunderson, MD Camille-Gunderson@ouhsc.edu | |
Contact: Stephanie Robbins, BS 405-271-8001 ext 31453 robbins@ouhsc.edu | |
Principal Investigator: Camille Gunderson, 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 |
Study Chair: | Thomas Herzog, MD | University of Cincinnati |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 11, 2019 | ||||||
First Posted Date ICMJE | May 14, 2019 | ||||||
Last Update Posted Date | April 8, 2021 | ||||||
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 |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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. |
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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
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
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) 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Cordgenics, LLC | ||||||
Study Sponsor ICMJE | Cordgenics, LLC | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Cordgenics, LLC | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |