We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Belinostat and Carboplatin in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Carboplatin or Cisplatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00993616
First Posted: October 12, 2009
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: December 5, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Brenner Tumor
Fallopian Tube Cancer
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Interventions: Drug: belinostat
Drug: carboplatin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment

Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.

belinostat: Given IV

carboplatin: Given IV


Participant Flow:   Overall Study
    Treatment
STARTED   29 
COMPLETED   27 [1] 
NOT COMPLETED   2 
No tumor at entry                1 
Never treated                1 
[1] Number of eligible and evaluable participants



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of eligible and evaluable participants

Reporting Groups
  Description
Treatment

Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.

belinostat: Given IV

carboplatin: Given IV


Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.2  (6.8) 
Age, Customized 
[Units: Participants]
 
40-49 years   2 
50-59 years   8 
60-69 years   15 
70-79 years   2 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      27 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   27 
Cell Type 
[Units: Participants]
 
Adenocarcinoma, Unspecified   1 
Clear Cell Carcinoma   2 
Mixed Epithelial Carcinoma   1 
Serous Adenocarcinoma   23 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1)   [ Time Frame: From study entry, up to 5 years ]

2.  Primary:   Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0   [ Time Frame: Every cycle during treatment and 30 days after the end of treatment ]

3.  Primary:   Progression Free Survival at 6 Months   [ Time Frame: Every other cycle for 6 months ]

4.  Other Pre-specified:   Duration of Progression-free Interval for All Patients   [ Time Frame: up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Melissa Leventhal
Organization: Gynecologic Oncology Group Statistical and Data Center
phone: 716-845-4030
e-mail: mleventhal@gogstats.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00993616     History of Changes
Other Study ID Numbers: NCI-2010-01663
NCI-2010-01663 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000656707
GOG-0126T ( Other Identifier: Gynecologic Oncology Group )
GOG-0126T ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: October 9, 2009
First Posted: October 12, 2009
Results First Submitted: December 5, 2013
Results First Posted: January 21, 2014
Last Update Posted: November 21, 2017