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Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00096447
Recruitment Status : Completed
First Posted : November 10, 2004
Results First Posted : September 18, 2015
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Recurrent Endometrial Carcinoma
Intervention: Drug: lapatinib ditosylate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was activated on 11/1/2004 and closed to accrual on 9/26/2005.

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
GW572016 1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy

Participant Flow:   Overall Study
    GW572016
STARTED   31 
COMPLETED   30 [1] 
NOT COMPLETED   1 
Never treated                1 
[1] Eligible and treated patients.



  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.
Eligible and treated patients.

Reporting Groups
  Description
GW572016 1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy

Baseline Measures
   GW572016 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.0  (11.1) 
Age, Customized 
[Units: Participants]
 
30-39 years   2 
40-49 years   4 
50-59 years   3 
60-69 years   13 
70-79 years   8 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      30 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   30 
International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent 
[Units: Participants]
 30 
Histologic Type 
[Units: Participants]
 
Adenocarcinoma, Unspecified   2 
Clear Cell Carcinoma   3 
Endometrioid Adenocarcinoma   16 
Mixed Epithelial Carcinoma   2 
Serous Adenocarcinoma   7 


  Outcome Measures

1.  Primary:   Percentage of Patients With Progression-free Survival > 6 Months   [ Time Frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years. ]

2.  Primary:   Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0   [ Time Frame: Every cycle during treatment and 30 days after the last cycle of therapy. ]

3.  Secondary:   Percentage of Patients With Tumor Response   [ Time Frame: For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years. ]

4.  Secondary:   Duration of Progression-free Survival   [ Time Frame: Every other cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. ]

5.  Secondary:   Overall Survival   [ Time Frame: From study entry to death or last contact, up to 5 years. ]

6.  Secondary:   Prognostic Factors (Performance Status)   [ Time Frame: Baseline ]

7.  Secondary:   Prognostic Factor (Histologic Grade)   [ Time Frame: Baseline ]


  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
The clinical trial was a two-stage design, accruing approximately 25 patients in each stage. Results from a planned interim futility analysis resulted in the early closure of the study. This study stopped early for lack of treatment efficacy.


  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: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
phone: 716-845-7733
e-mail: kurasa@nrgoncology.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096447     History of Changes
Other Study ID Numbers: NCI-2012-02631
GOG-0229D
U10CA027469 ( U.S. NIH Grant/Contract )
CDR0000393398 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: November 9, 2004
First Posted: November 10, 2004
Results First Submitted: June 3, 2015
Results First Posted: September 18, 2015
Last Update Posted: December 4, 2017