Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase I Pharmacokinetic Study of Intraperitoneal CTEP-Supplied Agent Bortezomib (PS-341, NSC 681239) and Carboplatin (NSC# 241240) in Patients With Persistent or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This phase I trial studies the side effects and best dose of intraperitoneal bortezomib when given together with intraperitoneal carboplatin in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that is persistent or has come back. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may help carboplatin work better by making tumor cells more sensitive to the drug. Infusing bortezomib and carboplatin directly into the abdomen (intraperitoneal) may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLTs) of
intraperitoneal (IP) bortezomib (BTZ) when administered with intraperitoneal 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
route.
SECONDARY OBJECTIVES:
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 dose-escalation study of bortezomib.
Patients receive bortezomib intraperitoneally (IP) and carboplatin IP on day 1. Treatment
repeats every 21 days for 6 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
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