Intraperitoneal Bortezomib and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Fallopian Tube Serous Adenocarcinoma
Fallopian Tube Transitional Cell Carcinoma
Malignant Ovarian Mixed Epithelial Tumor
Ovarian Brenner Tumor
Ovarian Clear Cell Adenocarcinoma
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Adenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Transitional Cell Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Undifferentiated Fallopian Tube Carcinoma
Undifferentiated Ovarian Carcinoma
Other: Laboratory Biomarker Analysis
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 defined by drug-related adverse events which occur in association with the first course of treatment as evaluated by the NCI CTCAE version 4 unless clearly unrelated to study drugs (e.g., disease progression) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- Frequency and severity of toxicities as assessed by NCI CTCAE version 4 [ 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 ]Objective tumor response will be tabulated by regimen.
- Pharmacokinetic parameters [ 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 ]Descriptive analysis will be given for the pharmacokinetic parameters of bortezomib and carboplatin.
- Progression free survival [ Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed up to 1 year ] [ Designated as safety issue: No ]Will be summarized using Kaplan-Meier plots.
|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.
Other Names:Drug: Carboplatin
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
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.
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.
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/Holden Comprehensive Cancer Center|
|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 Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Don Dizon||NRG Oncology|