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Gynecol Oncol. 2018 Jul;150(1):9-13. doi: 10.1016/j.ygyno.2018.04.572. Epub 2018 May 5.

Phase II study of single-agent cabozantinib in patients with recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer (NRG-GY001).

Author information

Gynecologic Medical Oncology Program, Dana-Farber Cancer Institute, Boston, MA, United States. Electronic address:
NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Cancer Institute, Buffalo, NY, United States. Electronic address:
Department of Obstetrics & Gynecology, Uniformed Serviced University of the Health Sciences, Bethesda, MD, United States. Electronic address:
Obstetrics and Gynecology, CWRU School of Medicine, Cleveland, OH, United States. Electronic address:
Gynecologic Oncology, Medical School of Wisconsin, Milwaukee, WI 53226, United States. Electronic address:
Department of Gynecologic Oncology & Reproductive Medicine, Unit 1362, The University of Texas, MD Anderson Cancer Center, Houston, TX, United States. Electronic address:



To evaluate the efficacy and tolerability of cabozantinib in recurrent clear cell ovarian, primary peritoneal or fallopian tube cancer.


Patients with recurrent ovarian, fallopian or primary peritoneal tumors with at least 50% clear cell histomorphology, measurable disease, one or two prior regimens and ECOG performance status 0-2 received cabozantinib 60 mg orally once daily continuously, in 4-week cycles until disease progression or unacceptable toxicity. Primary endpoints were progression-free survival (PFS) at six months and complete or partial tumor response (as assessed by RECIST 1.1). Secondary endpoints included toxicity, PFS, and overall survival (OS).


Over 19 months, 13 patients were accrued. Fifty-four percent of patients were ≥60 years of age. Performance statuses of 0 and 1 comprised 8 and 5 patients. No objective tumor responses were seen. Three (23% [95% CI: 5%, 54%]) of 13 patients had PFS ≥6 months, including one patient who received cabozantinib for 23 cycles and was still on treatment as of the data cut-off date. Median PFS and OS were 3.6 and 8.1 months, respectively. There was one patient with a grade 5 event: a thromboembolic event considered possibly related to study therapy; patient's cause of death was determined to be due to disease and protocol treatment. Four other patients had thromboembolic events (two grade 3 and one each grade 1 and grade 2). Other grade 3 or higher events reported in two or more patients were nausea, vomiting, fatigue, dyspnea, and dehydration.


Cabozantinib demonstrated minimal activity in the second- and third-line treatments of clear cell ovarian, fallopian tube or primary peritoneal carcinoma.


Anti-angiogenic therapy; Cabozantinib; Clear cell ovarian cancer; MET inhibition

[Available on 2019-07-01]
[Indexed for MEDLINE]

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