This pilot early phase I trial studies how adavosertib affects the tumor deoxyribonucleic
acid (DNA) of patients undergoing surgery for high grade (fast growing or aggressive)
ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the
body (advanced). Certain characteristics in the DNA of these patients may affect how well
they respond to treatment. Learning how adavosertib affects DNA in tumor cells may help
doctors plan effective treatment.
I. To explore baseline levels and effects of adavosertib (AZD1775) on DNA copy number,
mutation, and level of ribonucleic acid (RNA) and protein expression (together described as
"molecular results") in tumor protein p53 (p53)-related pathways before and after treatment
in women with primary advanced high grade serous ovarian, fallopian tube, or primary
I. To correlate molecular results to clinical endpoints including response and survival.
II. To correlate molecular results to pathologic endpoints including tumor volume and
III. To compare DNA copy number and level of RNA and protein expression in p53-related
pathways in tissue from patients treated with AZD1775 to those untreated with AZD1775 in the
IV. To determine the toxicity of AZD1775 given preoperatively, with a focus on postoperative
V. To determine the feasibility of treating preoperatively with AZD1775.
Patients receive adavosertib orally (PO) once daily (QD) on days 1-5. Patients then undergo
standard of care laparoscopy. Patients may also receive adavosertib PO QD on days 8-12,
15-19, and 22-26 for up to 28 days based on surgery schedule.
After completion of study treatment, patients are followed up at 30 days and then every 3
Advanced Fallopian Tube Carcinoma, Advanced Ovarian Carcinoma, Advanced Primary Peritoneal Carcinoma, Carcinomatosis, Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma, Stage III Fallopian Tube Cancer AJCC v7, Stage III Ovarian Cancer AJCC v6 and v7, Stage III Primary Peritoneal Cancer AJCC v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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