this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given.
Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid, carcinosarcoma, mixed Mullerian with high grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer.
Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant setting with planned interval debulking surgery.
Participant that is a candidate for neoadjuvant chemotherapy has a CA-125 (kilounits/L) : carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25 [Vergote, I., et al 2010].
Absolute neutrophil count (ANC) ≥1500/μL
Participant has mucinous, germ cell, or borderline tumor of the ovary.
Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis.
Participant either has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML.
Participant has a known additional malignancy that is progressing or has required active treatment in the last 3 years.
University of Alabama at Birmingham
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator