Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer

NCT03632798 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: CG02EOC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this randomized clinical study is to confirm the utility of chemosensitivity (ChemoID) tumor testing on cancer stem cells as a predictor of clinical response in recurrent epithelial ovarian cancer (EOC), fallopian tube, or primary peritoneal cancer, regardless of platinum sensitivity. Population studied will be female participants experiencing a 1st, 2nd, or 3rd recurrence of any stage epithelial ovarian cancer.

Conditions

Recurrent Ovarian Cancer

Keywords

ChemoID; cancer stem cells; drug response assay; ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Progression free survival (PFS) in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (Bevacizumab plus chemotherapy chosen by the Physician from the provided list) versus Bevacizumab plus ChemoID drug response assay-directed chemotherapy.

  36 months

Secondary Outcomes (3)

• Median Overall Survival (OS)

  36 months

• Objective Tumor Response

  36 months

• HRQOL

  36 months

Study Arms (2)

Physician Choice treatment

ACTIVE COMPARATOR

Participants will be treated with control chemotherapy treatment (Bevacizumab plus 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: Chemotherapy

ChemoID-guided treatment

EXPERIMENTAL

Participants will be treated with Bevacizumab plus 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; Drug: Chemotherapy

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 not only bulk of tumor cells, but importantly the 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.

ChemoID-guided treatment; Physician Choice treatment

Chemotherapy DRUG

Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent ovarian cancer. Chemotherapy list: * Liposomal Doxorubicin; * Docetaxel; * Paclitaxel; * Carboplatin; * Cisplatin; * Gemcitabine; * Topotecan; * Carboplatin, Gemcitabine; * Cisplatin, Gemcitabine; * Carboplatin, Liposomal Doxorubicin; * Carboplatin, Paclitaxel; * Carboplatin, Docetaxel.

Also known as: List of cytotoxic chemotherapy drugs

ChemoID-guided treatment; 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;
• \. Willing and able to commit to study procedures including long-term follow-up visit(s);
• \. At least 18 years old at the time of enrollment;
• \. Negative pregnancy test for women of childbearing potential
• \. Experiencing 1st, 2nd, or 3rd recurrent epithelial ovarian cancer of any stage regardless of platinum sensitivity, (platinum-sensitive, -resistant, or -refractory);
• \. Histopathological or cytological confirmation of recurrent epithelial ovarian carcinoma, peritoneal cancer or fallopian tube cancer.
• \. Evaluable disease - defined as RECIST 1.1 measurable disease OR not measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a CA125 \> 2x ULN).
• \. At least 30 days post-cytotoxic chemotherapy and/or monoclonal antibody therapy prior to enrollment;
• \. Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to Grade 1 as per CTCAE v4.0 (http://ctep.cancer.gov/protocol development/electronic\_applications/ctc.htm). Patients with long-standing stable grade 2 neuropathy may be considered after discussion with the Study Chair.
• \. ECOG Performance Status Score of ≤ 2, KPS≥70, or 0-1 GOG status
• \. Adequate laboratory values within 60 days of enrollment to study defined as follows:
• WBC ≥ 3000/mm3
• Hgb ≥ 10 mg/dl
• Hct ≥ 28%
• Platelet count ≥ 100,000/μL

You may not qualify if:

• \. Estimated life expectancy of \<6 months, as estimated by the investigator in consultation with participating oncologists;
• \. Ovarian cancer of a low grade serous, mucinous, or clear cell histology;
• \. Uncontrolled diabetes;
• \. Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24-hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR ≤ 1.0 to allow participation in the study;
• \. Symptomatic cardiac conditions;
• \. Contraindications to bevacizumab including uncontrolled hypertension, known arterial or venous thromboembolism, known nephrotic syndrome, history of abdominal fistula, GIP, or intra-abdominal abscess; clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition; nonhealing wound, ulcer, or bone fracture; bleeding diathesis or significant coagulopathy; known CNS disease, clinically significant cardiovascular disease; and a major surgical procedure within 28 days of enrollment or anticipated to occur while participating in study;
• \. 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).
• \. Documented history of ovarian cancer of a low malignant potential phenotype or unclear cell histology.
• \. CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease
• \. Patients 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 (3)

Univeristy of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25326, United States

Location

Edwards Comprehensive Cancer Center - Cabell Huntington Hospital

Huntington, West Virginia, 25705, United States

Location

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

• Kelly J Wilkinson, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

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: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel group randomized controlled clinical trial

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: August 1, 2018
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: February 12, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)