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Erlotinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

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ClinicalTrials.gov Identifier: NCT00387894
Recruitment Status : Terminated (Insufficient accrual of population likely to benefit; progression in 6 patients)
First Posted : October 13, 2006
Results First Posted : May 17, 2013
Last Update Posted : June 4, 2013
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
Michael Prados, University of California, San Francisco

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adult Brain Tumors
Intervention Drug: erlotinib hydrochloride
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28
Hide Arm/Group Description Tarceva self-administered in an open-label, unblinded manner to all patients enrolled. During the treatment period, patients who are not receiving enzyme-inducing antiepileptic drugs (EIAED) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days from 150 to 200 mg/day or from 600 to 650 mg/day assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
Period Title: Overall Study
Started 6
Completed 5
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28
Hide Arm/Group Description erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
44
(27 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
1
  16.7%
Male
5
  83.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  16.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
5
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Disease Response Measured Objectively by MRI of Brain
Hide Description Lack of disease progression indicates response to treatment
Time Frame Every 8 weeks or as indicated
Hide Outcome Measure Data
Hide Analysis Population Description
5 participants evaluable while receiving study treatment
Arm/Group Title Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28
Hide Arm/Group Description:
erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Disease progression prior to 8 weeks 4
Disease responsive at 8 Weeks 1
Disease responsive at 16 Weeks 0
2.Secondary Outcome
Title Duration of Progress-free Survival (PFS)
Hide Description Patients with stable or responding disease will continue treatment until tumor progression is determined
Time Frame Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28
Hide Arm/Group Description:
erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
2 weeks PFS 1
3 weeks PFS 1
6 weeks PFS 2
12 weeks PFS 1
Time Frame 30 days after the last study treatment, thereafter for survival
Adverse Event Reporting Description Only AEs Grade 3 or higher were required to be collected as AEs, per protocol
 
Arm/Group Title Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28
Hide Arm/Group Description erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
All-Cause Mortality
Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
General disorders   
Seizure * [1]  1/6 (16.67%)  1
Confusion * [1]  1/6 (16.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Disease progression  [2]  6/6 (100.00%)  6
Nervous system disorders   
Neuropathy * [1]  1/6 (16.67%)  1
Skin and subcutaneous tissue disorders   
Wound complication * [1]  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Grade 3, not related to treatment
[2]
All participants died due to disease progression
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
The study was terminated early for 2 reasons: 1. ongoing literature at the time confirming that the selection process was not likely to enrich for a patient population expected to benefit, and 2. Rapid disease progression in the first 6 patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Prados, MD
Organization: University of California San Francisco
Phone: 415-353-7500
EMail: PradosM@neurosurg.ucsf.edu
Layout table for additonal information
Responsible Party: Michael Prados, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00387894    
Other Study ID Numbers: CDR0000492762
UCSF-06102 ( Other Identifier: OnCore )
UCSF-H5941-28905-01 ( Other Identifier: IRB Approval # )
GENENTECH-OSI3765s ( Other Identifier: Sponsor protocol ID )
First Submitted: October 12, 2006
First Posted: October 13, 2006
Results First Submitted: April 12, 2013
Results First Posted: May 17, 2013
Last Update Posted: June 4, 2013