Intraperitoneal Bortezomib and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT01074411|
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Serous Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma Ovarian Brenner Tumor Ovarian Clear Cell Adenocarcinoma Ovarian Clear Cell Cystadenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Adenocarcinoma Ovarian Mucinous Cystadenocarcinoma Ovarian Seromucinous Carcinoma 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||Drug: Bortezomib Drug: Carboplatin Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 5, 2010|
|Actual Primary Completion Date :||April 4, 2014|
|Actual Study Completion Date :||January 27, 2018|
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: Laboratory Biomarker Analysis
Other: Pharmacological Study
- 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 ]
- Frequency and severity of toxicities as assessed by NCI CTCAE version 4 [ Time Frame: Up to 1 year ]
- Objective tumor response (complete and partial response) [ Time Frame: Up to 1 year ]Objective tumor response will be tabulated by regimen.
- Progression free survival [ Time Frame: Time from study entry to time of progression or death, whichever occurs first, assessed up to 1 year ]Will be summarized using Kaplan-Meier plots.
- 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 ]Descriptive analysis will be given for the pharmacokinetic parameters of bortezomib and carboplatin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Oklahoma Cancer Specialists and Research Institute-Tulsa|
|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|