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:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00993616
First received: October 9, 2009
Last updated: June 18, 2014
Last verified: June 2014
Results First Received: December 5, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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
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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
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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  
Number of Participants  
[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  
Gender  
[units: participants]
 
Female     27  
Male     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

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 4.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Primary:   Survival Time for All Patients   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Primary:   Duration of Progression-free Interval for All Patients   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00993616     History of Changes
Other Study ID Numbers: NCI-2010-01663, NCI-2010-01663, CDR0000656707, GOG-0126T, GOG-0126T, U10CA027469
Study First Received: October 9, 2009
Results First Received: December 5, 2013
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration