Study on Chemotherapy Guided by Cancer Stem Cell Testing for Recurrent Platinum-Resistant Ovarian Cancer
Sponsor: Cordgenics, LLC
ClinicalTrials ID:NCT03949283
This clinical trial is exploring whether using a special test called ChemoID to guide chemotherapy choices can improve treatment outcomes for women with recurrent ovarian cancer that doesn't respond to platinum-based treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to see if using a test called ChemoID, which checks how cancer stem cells respond to different chemotherapy drugs, can help predict which treatments will work best for women with recurrent ovarian cancer that is resistant to platinum-based drugs. The study involves women with ovarian, fallopian tube, or primary peritoneal cancer who have had up to five previous treatments and are in good health.
Description
This study is a randomized controlled trial, meaning participants are randomly assigned to different treatment groups. It will compare the outcomes of women with recurrent platinum-resistant ovarian cancer who receive chemotherapy based on the ChemoID test results to those who receive standard chemotherapy chosen by their doctor.
Participants will first provide informed consent and then undergo a biopsy or fluid collection to test their cancer cells with the ChemoID assay. This test will help determine which FDA-approved chemotherapy drugs might be most effective for them.
Participants will be randomly assigned to one of two groups: one group will receive standard chemotherapy chosen by their doctor, and the other group will receive chemotherapy based on the ChemoID test results. The assignment will consider factors like the number of previous platinum treatments and BRCA status to ensure balanced groups.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent and be willing to follow study procedures, including long-term follow-up.
- Female, at least 18 years old.
- Negative pregnancy test for women who can have children.
- Diagnosed with recurrent platinum-resistant ovarian, peritoneal, or fallopian tube cancer.
- Must have measurable or evaluable disease, as defined by specific medical criteria.
- Agree to provide a tumor sample for ChemoID testing.
- Cancer must be of specific types, such as high-grade serous adenocarcinoma or endometrioid adenocarcinoma.
- Have had no more than five previous treatments, including at least one platinum-based regimen.
- Expected to live more than six months.
- Require chemotherapy, with a plan to use one of the study's chemotherapy regimens.
- Good overall health, with specific performance status scores.
- Adequate blood and organ function based on lab tests.
Exclusion Criteria
- Planned use of Avastin for treatment.
- Have certain types of ovarian tumors, like stromal or germ cell tumors.
- Have borderline, mucinous, or low-grade serous carcinoma.
- Pregnant or breastfeeding.
- Not using effective birth control if able to have children.
- Unable to comply with study visits and procedures, including due to psychiatric conditions.
- Expected to live less than six months.
- Have serious heart conditions.
- Enrolled in another study that limits chemotherapy choices.
- Previously participated in this study.
- Any condition that poses a risk or prevents meeting study requirements.
- Only have CA-125 disease without measurable or evaluable disease.
- Only have fluid buildup as a site of disease.
- Using alternative medicines that might interfere with the study treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Kaiser Permanente | 90027 | Los Angeles | California |
| Miami Cancer Institute/Baptist Health South Florida | 33176 | Miami | Florida |
| LSU Health Sciences Center | 70112 | New Orleans | Louisiana |
| University of Cincinnati Cancer Institute | 45221 | Cincinnati | Ohio |
| University of Oklahoma Health Sciences Center | 73104 | Oklahoma City | Oklahoma |
| West Penn Hospital, Allegheny Health Network | 15224 | Pittsburgh | Pennsylvania |
| Charleston Area Medical Center (CAMC) | 25304 | Charleston | West Virginia |
| Edwards Comprehensive Cancer Center - Cabell Huntington Hospital | 25701 | Huntington | West Virginia |
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