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Trial record 33 of 150 for:    vulvar cancer

Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

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ClinicalTrials.gov Identifier: NCT00476476
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : March 19, 2015
Last Update Posted : May 7, 2015
Sponsor:
Collaborators:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Neil S. Horowitz, MD, Dana-Farber Cancer Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Squamous Cell Carcinoma
Intervention: Drug: Erlotinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled from February 2007 through July 2011.

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
Erlotinib-Cohort 1 Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
Erlotinib-Cohort 2 Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.

Participant Flow:   Overall Study
    Erlotinib-Cohort 1   Erlotinib-Cohort 2
STARTED   17   24 
Response Evaluable   17   23 [1] 
COMPLETED   15   0 [2] 
NOT COMPLETED   2   24 
Adverse Event                2                7 
Progressive Disease                0                17 
[1] One woman was unevaluable due to an allergic reaction that developed after the 2nd dose.
[2] Treatment was not of fixed duration and thus pts are not considered to have 'Completed' treatment.



  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 population is comprised of all enrolled patients.

Reporting Groups
  Description
Erlotinib-Cohort 1 Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
Erlotinib-Cohort 2 Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
Total Total of all reporting groups

Baseline Measures
   Erlotinib-Cohort 1   Erlotinib-Cohort 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   24   41 
Age 
[Units: Years]
Mean (Full Range)
 75 
 (58 to 94) 
 71.5 
 (49 to 86) 
 73 
 (49 to 94) 
Gender 
[Units: Participants]
     
Female   17   24   41 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   17   24   41 


  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts). ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Neil Horowitz MD
Organization: Dana-Farber Cancer Institute
phone: 617.732.8843
e-mail: NHOROWITZ@mgh.harvard.edu


Publications of Results:

Responsible Party: Neil S. Horowitz, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00476476     History of Changes
Other Study ID Numbers: 06-174
First Submitted: May 18, 2007
First Posted: May 22, 2007
Results First Submitted: March 8, 2015
Results First Posted: March 19, 2015
Last Update Posted: May 7, 2015