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S0330 Erlotinib in Treating Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor

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: NCT00068367
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sarcoma
Intervention: Drug: erlotinib hydrochloride

  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
Four patients enrolled to study were found to be ineligible. One patient did not have measurable disease, one patient had radiotherapy 19 days prior to registration and two patients were found ineligible upon pathology review.

Reporting Groups
  Description
Arm I (OSI-774) OSI-774 150 mg daily for 25 weeks

Participant Flow:   Overall Study
    Arm I (OSI-774)
STARTED   20 
COMPLETED   20 
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
Arm I (OSI-774) OSI-774 150 mg daily for 25 weeks

Baseline Measures
   Arm I (OSI-774) 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Median (Full Range)
 45.3 
 (19.8 to 76.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  40.0% 
Male      12  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  10.0% 
Not Hispanic or Latino      16  80.0% 
Unknown or Not Reported      2  10.0% 
Prior multi-agent chemotherapy 
[Units: Participants]
Count of Participants
 
Yes      14  70.0% 
No      6  30.0% 


  Outcome Measures

1.  Primary:   Patients With Response (Confirmed Complete, and Partial) With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumor When Treated With Erlotinib.   [ Time Frame: 25 weeks ]

2.  Secondary:   Toxicity   [ Time Frame: Up to 25 weeks ]

3.  Other Pre-specified:   Correlate, Preliminarily, Indicators of Epidermal Growth Factor Receptor (EGFR) Function With Response and Progression-free and Overall Survival in Patients Treated With This Drug.   [ Time Frame: ]

4.  Other Pre-specified:   Feasibility of Accruing These Patients in the Cooperative Group Setting   [ Time Frame: ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623
e-mail: sarcoma@crab.org


Publications of Results:
Albritton KH, Rankin C, Coffin CM, et al.: Phase II study of erlotinib in metastatic or unresectable malignant peripheral nerve sheath tumors (MPNST). [Abstract] J Clin Oncol 24 (Suppl 18): A-9518, 524s, 2006.


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00068367     History of Changes
Other Study ID Numbers: CDR0000322023
S0330 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: April 20, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017