Intraperitoneal Bortezomib and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
This phase I trial is studying the side effects and best dose of intraperitoneal bortezomib when given together with intraperitoneal carboplatin in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. 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 or by stopping them from dividing. Bortezomib may help carboplatin work better by making tumor cells more sensitive to the drug. Infusing bortezomib and carboplatin directly into the abdomen may kill more tumor cells.
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Dose-limiting toxicities during the first course of therapy [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- Frequency and severity of toxicities as assessed by NCI CTCAE criteria [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
- Objective tumor response (complete and partial response) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Pharmacokinetic measures of bortezomib [ Time Frame: 10 minutes prior to infusion; immediately following infusion; 15, 30 and 60 minutes after infusion; immediately following carboplatin; 90 minutes after infusion; and 2, 4, and 6 hours after infusion ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (bortezomib, carboplatin)
Patients receive bortezomib 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.
Other Names:Drug: carboplatin
Other Names:Other: pharmacological study
Other Name: pharmacological studies
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 route.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074411
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|The Hospital of Central Connecticut|
|New Britain, Connecticut, United States, 06050|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Cooper Hospital University Medical Center|
|Camden, New Jersey, United States, 08103|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Cancer Center/Fairview Hospital|
|Cleveland, Ohio, United States, 44111|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Hillcrest Hospital Cancer Center|
|Mayfield Heights, Ohio, United States, 44124|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Tulsa Cancer Institute|
|Tulsa, Oklahoma, United States, 74146|
|United States, Rhode Island|
|Women and Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Don Dizon||Gynecologic Oncology Group|