Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer
- Conditions
- Recurrent Ovarian CarcinomaPlatinum-resistant Ovarian Cancer
- Registration Number
- NCT03949283
- Lead Sponsor
- Cordgenics, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Informed consent obtained and signed.<br><br> 2. Participant is willing and able to commit to study procedures including long-term<br> follow-up visit(s);<br><br> 3. Participant must be a female and at least 18 years of age at the time of enrollment.<br><br> 4. Negative pregnancy test for women of childbearing potential.<br><br> 5. Participant has been diagnosed with recurrent platinum resistant epithelial ovarian,<br> peritoneal, or fallopian tube carcinoma.<br><br> 6. Participants must have an evaluable disease - defined as one of the following:<br><br> 1) RECIST 1.1 measurable disease (defined as one or more solid and/or cystic tumors on<br> cross-sectional imaging that measures 1 cm or greater in long axis and/or lymph<br> nodes measuring 1.5 cm or greater in short axis) 2) Evaluable disease (defined as<br> solid and/or cystic tumors on radiographic imaging or physical exam that do not meet<br> RECIST 1.1 definitions for target lesions) with elevated CA125 (GCIG recurrence and<br> response criteria) by more than 2 times the upper limits of normal, confirmed in two<br> successive samples, drawn at least one week apart).<br><br> 7. Participant has agreed to provide a core biopsy of the primary site, a secondary<br> metastatic site, or to undergo a paracentesis or thoracentesis for fluid collection.<br><br> 8. An adequate fresh sample can be provided and submitted for ChemoID testing.<br><br> 9. Participant has disease of one of the following histologic epithelial cell types:<br> high-grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated<br> carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not<br> otherwise specified (N.O.S.). Cytologic confirmation of diagnosis is acceptable for<br> participants treated with neoadjuvant therapy who have not had a surgical procedure<br> for a histologic confirmation. Patients with low-grade serous or mucinous<br> adenocarcinoma are not eligible, nor are patients with pure ovarian sarcomas.<br><br> 10. Participant has received = 5 prior regimens including at least one platinum-based<br> regimen for their ovarian, peritoneal, or fallopian tube carcinoma.<br><br> 11. Participant must have an estimated life expectancy of greater than six months, as<br> determined by the investigator.<br><br> 12. Participant requires chemotherapy and the investigator plans to administer one of<br> the regimens of interest as deemed by her physician.<br><br> 13. Participant must have an ECOG Performance Status Score of = 2, KPS=70, or 0-2 GOG<br> status.<br><br> 14. Adequate laboratory values within 60 days of enrollment to study defined as follows:<br><br> 1. ANC = 1500/mm3<br><br> 2. Hgb = 10 mg/dl<br><br> 3. Hct = 28%<br><br> 4. Platelet count = 100,000/µL<br><br> 5. Serum creatinine = 2.0 mg/dl<br><br> 6. Total bilirubin = 2.5 mg/dl<br><br> 7. AST/SGOT = 3 times ULN. If intrahepatic liver metastases are present, AST and ALT<br> must be = 5 times institutional ULN.<br><br>Exclusion Criteria:<br><br> 1. Use of Avastin planned to treat participant.<br><br> 2. Participant has ovarian stromal, germ cell tumors or pure sarcomas.<br><br> 3. Participant has borderline carcinoma (uncertain malignant potential), mutinous or<br> low-grade serous carcinoma.<br><br> 4. Participant is pregnant or lactating.<br><br> 5. Participants of childbearing potential not employing adequate contraception.<br><br> 6. Participants who are at risk of failure of compliance to the visit schedules and<br> procedures including those with psychiatric disease that would substantially impact<br> compliance or consent.<br><br> 7. Estimated life expectancy of <6 months, as estimated by the investigator in<br> consultation with participating oncologists.<br><br> 8. Participants with symptomatic cardiac conditions (i.e. NYHA class III/IV or<br> uncompensated angina).<br><br> 9. Enrollment in another clinical study that precludes allowing the oncologist to<br> select chemotherapy regimens.<br><br> 10. Previously participated in this study.<br><br> 11. Any condition that would, in the opinion of the investigator, place the participant<br> at an unacceptable risk, or render the participant unable to meet the requirements<br> of the protocol (including long-term study follow-up).<br><br> 12. CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease.<br><br> 13. Patients with third space fluid (for example pleural effusions) as only site of<br> disease.<br><br> 14. Participant may not use any complementary or alternative medicines including natural<br> herbal products or folk remedies as they may interfere with the effectiveness of the<br> study treatments.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS);Duration of Response;CA125 levels;Health-Related Quality of Life (HRQOL)