Recurrent Ovarian CancerPhase 3ACSCONCT03632798
Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer
A Phase 3 study testing ChemoID assay and Chemotherapy in people with Recurrent Ovarian Cancer, run by Cordgenics, LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer
- What is being tested?
- ChemoID assay and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2018to 10 Jun 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 1. Informed consent obtained and signed;
- 2. Willing and able to commit to study procedures including long-term follow-up visit(s);
- 3. At least 18 years old at the time of enrollment;
- 4. Negative pregnancy test for women of childbearing potential
- 5. Experiencing 1st, 2nd, or 3rd recurrent epithelial ovarian cancer of any stage regardless of platinum sensitivity, (platinum-sensitive, -resistant, or -refractory);
- 6. Histopathological or cytological confirmation of recurrent epithelial ovarian carcinoma, peritoneal cancer or fallopian tube cancer.
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- 7. 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).
- 8. At least 30 days post-cytotoxic chemotherapy and/or monoclonal antibody therapy prior to enrollment;
- 9. 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.
- 10. ECOG Performance Status Score of ≤ 2, KPS≥70, or 0-1 GOG status
- 11. 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
- 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.
- Random urine protein/creatinine ratio ≤ 1 or 24 hour urine protein < 0.1 gram.
- 12. Appropriate for tissue sampling either by tumor biopsy or peritoneal or pleural fluid collection.
Who cannot join
- 1. Estimated life expectancy of <6 months, as estimated by the investigator in consultation with participating oncologists;
- 2. Ovarian cancer of a low grade serous, mucinous, or clear cell histology;
- 3. Uncontrolled diabetes;
- 4. 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;
- 5. Symptomatic cardiac conditions;
- 6. 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;
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- 7. Enrollment in another clinical study that precludes allowing the oncologist to select chemotherapy regimens;
- 8. Previously participated in this study;
- 9. 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).
- 10. Documented history of ovarian cancer of a low malignant potential phenotype or unclear cell histology.
- 11. CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease
- 12. 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Charleston Area Medical Center
Charleston, West Virginia, 25326
Edwards Comprehensive Cancer Center - Cabell Huntington Hospital
Huntington, West Virginia, 25705
Univeristy of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Platinum-Resistant or -Sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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.
Read the detailed description
This study is designed as a parallel group randomized controlled clinical trial to determine if recurrent Epithelial Ovarian Cancer (EOC) patients treated with Bevacizumab plus drugs predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy (Bevacizumab plus chemotherapy chosen by the Physician).
Upon obtaining informed consent, all eligible participants affected by 1st, 2nd, or 3rd relapse of EOC regardless of platinum sensitivity (both platinum sensitive and resistant) 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 (Bevacizumab plus chemotherapy chosen by the Physician from the provided list), or to a study arm of Bevacizumab plus 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 relapse number, platinum sensitivity, and study site to ensure balance within these cells.
- Conditions
- Recurrent Ovarian Cancer
- Being tested
- ChemoID assay, Chemotherapy
- Keywords
- ChemoID, cancer stem cells, drug response assay, ovarian cancer
- 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
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.
ChemotherapyDrug
Also called List of cytotoxic chemotherapy drugs
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: ChemoID assay; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (3)
Median Overall Survival (OS)
Overall survival (OS) in patients with recurrent 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.
Measured: 36 months
Objective Tumor Response
ORR: partial or complete response by RECIST v1.1 (Response Evaluation Criteria In Solid Tumors)
Measured: 36 months
HRQOL
Health-Related Quality of Life (HRQOL)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Aug 2018
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordgenics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelly J Wilkinson, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632798
- Sponsor's protocol ID
- CG02EOC
- Acronym
- ACSCO
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2018
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Platinum-Resistant or -Sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT03632798
- Acronym / sponsor ID
- ACSCO / CG02EOC
- Conditions
- Recurrent Ovarian Cancer
- Keywords
- ChemoID, cancer stem cells, drug response assay, ovarian cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cordgenics, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed as a parallel group randomized controlled clinical trial to determine if recurrent Epithelial Ovarian Cancer (EOC) patients treated with Bevacizumab plus drugs predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy (Bevacizumab plus chemotherapy chosen by the Physician).
Upon obtaining informed consent, all eligible participants affected by 1st, 2nd, or 3rd relapse of EOC regardless of platinum sensitivity (both platinum sensitive and resistant) 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 (Bevacizumab plus chemotherapy chosen by the Physician from the provided list), or to a study arm of Bevacizumab plus 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 relapse number, platinum sensitivity, and study site to ensure balance within these cells.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel group randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Physician Choice treatment | Active comparator | Diagnostic Test: ChemoID assay, Drug: ChemotherapyParticipants 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. |
| ChemoID-guided treatment | Experimental | Diagnostic Test: ChemoID assay, Drug: ChemotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 1. Informed consent obtained and signed;
- 2. Willing and able to commit to study procedures including long-term follow-up visit(s);
- 3. At least 18 years old at the time of enrollment;
- 4. Negative pregnancy test for women of childbearing potential
- 5. Experiencing 1st, 2nd, or 3rd recurrent epithelial ovarian cancer of any stage regardless of platinum sensitivity, (platinum-sensitive, -resistant, or -refractory);
Key exclusion criteria (12 listed)
- 1. Estimated life expectancy of <6 months, as estimated by the investigator in consultation with participating oncologists;
- 2. Ovarian cancer of a low grade serous, mucinous, or clear cell histology;
- 3. Uncontrolled diabetes;
- 4. 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;
- 5. Symptomatic cardiac conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoID assayThe 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. | Diagnostic test | ChemoID-guided treatment, Physician Choice treatment |
| ChemotherapyAlso: List of cytotoxic chemotherapy drugsChemotherapies 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. | Drug | ChemoID-guided treatment, Physician Choice treatment |
Primary outcome
Progression free survival (PFS)
Time frame: 36 months
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.
3 secondary outcomes
Median Overall Survival (OS)
Time frame: 36 months
Objective Tumor Response
Time frame: 36 months
HRQOL
Time frame: 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly J Wilkinson, MD principal investigator
University of Mississippi Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ChemoID assay and Chemotherapy in people with Recurrent Ovarian Cancer, run by Cordgenics, LLC at 3 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 20 inclusion and 12 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: withdrawn, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Progression free survival (PFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.