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| Overall Recruitment Status: Active, currently enrolling |
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| Official Title |
| Standard Chemotherapy Versus Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer |
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| Region |
Sponsors |
| California - Southern |
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| Acronym |
KP IRB No. |
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12411 |
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| Study Type |
Phase |
| Clinical Trial |
Phase III |
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| Study Population Description |
| (Adult, Older Adult) Female with diagnosed Recurrent Ovarian Carcinoma
Platinum-resistant Ovarian Cancer |
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| Purpose |
| 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. |
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| Detailed Description |
| his study is designed as a parallel group randomized controlled clinical trial to determine if recurrent platinum resistant epithelial ovarian cancer (EOC) patients treated with chemotherapy predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy chosen by the physician.
Upon obtaining informed consent, all eligible participants affected by recurrent platinum-resistant ovarian cancer (no mucinous, low grade serous, or pure sarcoma types), with <5 prior treatments, and a performance status 0-1 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 (chemotherapy chosen by the Physician from a provided list), or to a study arm of 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 number of prior platinum treatments and BRCA status to ensure balance within these cells. |
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| Gender |
Age Limit |
| Female |
18 years & older |
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- Informed consent obtained and signed
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Participant is willing and able to commit to study procedures including long-term follow-up visit(s)
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Participant must be a female and at least 18 years of age at the time of enrollment
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Negative pregnancy test for women of childbearing potential
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Participant has been diagnosed with recurrent platinum resistant epithelial ovarian, peritoneal, or fallopian tube carcinoma
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Participants must have an evaluable disease - defined as one of the following:
* 1) 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)
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Please contact study team for additional inclusion/exclusion criteria
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- Use of Avastin planned to treat participant
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Participant has ovarian stromal, germ cell tumors or pure sarcomas
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Participant has borderline carcinoma (uncertain malignant potential), mutinous or low-grade serous carcinoma
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Participant is pregnant or lactating
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Participants of childbearing potential not employing adequate contraception
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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
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Please contact study team for additional inclusion/exclusion criteria
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Neoplasms by Histologic Type
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Carcinoma, Ovarian Epithelial
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Neoplasms, Glandular and Epithelial
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Endocrine Gland Neoplasms
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Endocrine System Diseases
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Genital Neoplasms, Female
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