We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00768144
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : December 2, 2014
Last Update Posted : June 5, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Intervention: Drug: Sunitinib

  Participant Flow

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

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]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      26  72.2% 
>=65 years      10  27.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      36 100.0% 
Male      0   0.0% 
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

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

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

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
First Submitted: September 29, 2008
First Posted: October 7, 2008
Results First Submitted: June 5, 2014
Results First Posted: December 2, 2014
Last Update Posted: June 5, 2017