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

NCT03949283 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CG03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

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.

Conditions

Recurrent Ovarian Carcinoma; Platinum-resistant Ovarian Cancer

Keywords

Ovarian cancer; Platinum resistant; ChemoID; Cytotoxicity assay; Cancer Stem Cells

Outcome Measures

Primary Outcomes (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).

  24 months

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  24 months

• Duration of Response

  24 months

• CA125 levels

  24 months

• Health-Related Quality of Life (HRQOL)

  24 months

Study Arms (2)

Physician Choice Treatment

ACTIVE COMPARATOR

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; Drug: Standard Chemotherapy

ChemoID-guided treatment

EXPERIMENTAL

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

Interventions

ChemoID Assay DIAGNOSTIC_TEST

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.

Also known as: Chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs)

ChemoID-guided treatment; Physician Choice Treatment

Standard Chemotherapy DRUG

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.

Also known as: Chemotherapy

Physician Choice Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Ovarian Cancer is a female disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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).
• \. 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.
• \. An adequate fresh sample can be provided and submitted for ChemoID testing.
• \. 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.
• \. Participant has received ≤ 5 prior regimens including at least one platinum-based regimen for their ovarian, peritoneal, or fallopian tube carcinoma.
• \. Participant must have an estimated life expectancy of greater than six months, as determined by the investigator.
• \. Participant requires chemotherapy and the investigator plans to administer one of the regimens of interest as deemed by her physician.
• \. Participant must have an ECOG Performance Status Score of ≤ 2, KPS≥70, or 0-2 GOG status.
• \. Adequate laboratory values within 60 days of enrollment to study defined as follows:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cordgenics, LLC: lead

Study Sites (8)

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

Miami Cancer Institute/Baptist Health South Florida

Miami, Florida, 33176, United States

Location

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45221, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

West Penn Hospital, Allegheny Health Network

Pittsburgh, Pennsylvania, 15224, United States

Location

Charleston Area Medical Center (CAMC)

Charleston, West Virginia, 25304, United States

Location

Edwards Comprehensive Cancer Center - Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

Related Publications (2)

• 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.

  PMID: 32862103 BACKGROUND

• 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.

  PMID: 34796266 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Thomas Herzog, MD

  University of Cincinnati

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel group randomized controlled clinical trial

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: May 14, 2019
• Study Start: July 26, 2019
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)