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Trial record 4 of 163 for:    ovarian cancer and Minnesota

Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

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: NCT00617188
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : March 17, 2010
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: Fulvestrant

  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
3 additional patients were enrolled, but were never treated.

Reporting Groups
  Description
Fulvestrant Treatment Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)

Participant Flow:   Overall Study
    Fulvestrant Treatment
STARTED   26 
COMPLETED   26 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
Fulvestrant Treatment Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)

Baseline Measures
   Fulvestrant Treatment 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  53.8% 
>=65 years      12  46.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      26 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   26 


  Outcome Measures

1.  Primary:   Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Day 90 ]

2.  Secondary:   Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin)   [ Time Frame: Day 90 ]

3.  Secondary:   Median Number of Days to Treatment Termination   [ Time Frame: Up to 373 Days ]

4.  Secondary:   Mean Scores - Quality of Life Assessment   [ Time Frame: Baseline, 3 Months Post Treatment, 6 Months Post Treatment ]

5.  Secondary:   Serum Skeletal-Specific Alkaline Phosphatase Concentration   [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months ]

6.  Secondary:   Urine N-telopeptide Concentration   [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months ]


  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: Peter Argenta, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-626-6037
e-mail: argenta@umn.edu


Publications of Results:

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00617188     History of Changes
Other Study ID Numbers: CDR0000582821
UMN-2007LS003 ( Other Identifier: Clinical Trials Office, University of Minnesota )
UMN-WCC-49 ( Other Identifier: Women's Cancer Center, University of Minnesota )
UMN-0612M97626 ( Other Identifier: IRB, University of Minnesota )
IRUSFULV0062 ( Other Identifier: AstraZeneca )
First Submitted: February 14, 2008
First Posted: February 15, 2008
Results First Submitted: June 12, 2009
Results First Posted: March 17, 2010
Last Update Posted: December 28, 2017