A PHASE I PHARMACOKINETIC STUDY OF INTRAPERITONEAL CTEP-SUPPLIED AGENT BORTEZOMIB (PS-341, NSC 681239, IND# 58443) AND CARBOPLATIN (NSC# 241240) IN PATIENTS WITH PERSISTENT OR RECURRENT OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER
I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of
intraperitoneal (IP) bortezomib (BTZ) when administered with IP carboplatin in women with
epithelial ovarian, fallopian tube, or primary peritoneal cancer that is persistent or
recurrent and who have failed primary therapy and at least one second-line therapy.
II. To examine the safety of administering BTZ in combination with carboplatin by the IP
I. To estimate objective tumor response rate as determined by Response Evaluation Criteria
in Solid Tumors (RECIST) 1.1 criteria.
II. To determine the pharmacokinetic profile of BTZ and carboplatin when administered
intraperitoneally once every 21 days.
III. To characterize the frequency of carboplatin hypersensitivity reactions (HSR) when
administered as an intraperitoneal infusion in the context of recurrent ovarian cancer.
OUTLINE: This is a multicenter, dose-escalation study of bortezomib.
Patients receive bortezomib intraperitoneal (IP) and carboplatin IP on day 1. Treatment
repeats every 21 days for 6 courses in the absence of disease progression or unacceptable
toxicity. Plasma and peritoneal fluid samples are collected at baseline and periodically
during the first course of therapy for pharmacokinetic studies.
After completion of study treatment, patients are followed every 3 months for 1 year.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicities during the first course of therapy
Gynecologic Oncology Group
United States: Food and Drug Administration
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Hartford Hospital||Hartford, Connecticut 06102-5037|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|University of Virginia||Charlottesville, Virginia 22908|
|Case Western Reserve University||Cleveland, Ohio 44106|
|Virginia Commonwealth University||Richmond, Virginia|
|The Hospital of Central Connecticut||New Britain, Connecticut 06050|
|Cooper Hospital University Medical Center||Camden, New Jersey 08103|
|Women and Infants Hospital||Providence, Rhode Island 02905|