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Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00768144
First received: September 29, 2008
Last updated: June 13, 2016
Last verified: June 2016
Results First Received: June 5, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Intervention: Drug: Sunitinib

  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
Participants were recruited from the GYN Oncology clinics at the DFCI, MGH and BIDMC. Thirty six consenting participants were enrolled over a 19 month period.

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
Sunitinib Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.

Participant Flow:   Overall Study
    Sunitinib
STARTED   36 
COMPLETED   0 
NOT COMPLETED   36 
Adverse Event                13 
Progressive Disease                21 
Patient or MD Decision to End Treatment                1 
Pt Withdrew Consent                1 



  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.
The analysis dataset is comprised of all enrolled patients.

Reporting Groups
  Description
Sunitinib Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.

Baseline Measures
   Sunitinib 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   26 
>=65 years   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (8.8) 
Gender 
[Units: Participants]
 
Female   36 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   36 
Histology 
[Units: Participants]
 
Papillary serous   23 
Endometrioid   2 
Clear cell   5 
Mixed Mullerian tumor   3 
Other (adenocarcinoma/mixed histology)   3 


  Outcome Measures
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1.  Primary:   Overall Response Rate   [ Time Frame: Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt. ]

2.  Secondary:   16-Week Progression-Free Survival   [ Time Frame: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment. ]

3.  Secondary:   Progression-Free Survival   [ Time Frame: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment. ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Susana M. Campos, MD, MPH
Organization: Dana-Farber Cancer Institute
phone: 617-632-5269
e-mail: susana_campos@dfci.harvard.edu



Responsible Party: Susana M. Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00768144     History of Changes
Other Study ID Numbers: 08-056
Study First Received: September 29, 2008
Results First Received: June 5, 2014
Last Updated: June 13, 2016
Health Authority: United States: Food and Drug Administration