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Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

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: NCT00445588
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : April 27, 2016
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Interventions Drug: erlotinib hydrochloride
Drug: sorafenib tosylate
Other: pharmacological study
Enrollment 56
Recruitment Details

Adult pts accured in an outpatient clinic between Jan 2007 and October 2007.

pts had to have measurable , histologically proven GBM, that had progressed following radiation therapy and 0-2 prior chemotherapies.

Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

Patients receive oral erlotinib hydrochloride 150 mg once daily and oral sorafenib tosylate 400 mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study

erlotinib hydrochloride 150mg: Given orally once daily

sorafenib tosylate 400mg: Given orally twice daily

pharmacological study: Correlative studies

Period Title: Overall Study
Started 56
Completed 56
Not Completed 0
Arm/Group Title Treatment
Hide Arm/Group Description

Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study

erlotinib hydrochloride: 150mg Given orally once daily

sorafenib tosylate: 400mg Given orally twice daily

pharmacological study: Correlative studies

Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
histologically confirmed GBM, progressed or recurred following RT and 0-2 prior chemotherapy regimens
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 56 participants
56
(31 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
21
  37.5%
Male
35
  62.5%
Karnosky Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants
90-100 26
60-80 30
[1]
Measure Description: 100 - Normal; no complaints; no evidence of disease 90 - Able to carry on normal activity; minor signs or symptoms of disease 80 - Normal activity with effort; some signs or symptoms of disease 70 - Cares for self; unable to carry on normal activity or to do active work 60 - Requires occasional assistance, but is able to care for most of his personal needs
1.Primary Outcome
Title Overall Survival
Hide Description death. measured by time of first day of treatment until date of death, assessed up to 2 years.
Time Frame Time of first day of the treatment to death, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study

erlotinib hydrochloride 150mg: Given orally once daily

sorafenib tosylate 400mg: Given orally twice daily

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 56
Median (95% Confidence Interval)
Unit of Measure: months
5.7
(4.5 to 7.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment
Comments The overall failure rate will be estimated by dividing the number of events (death) with the total exposure time in the study cohort. 95% confidence intervals and median time of survival will be calculated using standard methods.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments cox regression model was used to estimate the HR of death compared to NABTT historical control with same histology, adjusted for age, KPS, and surgical procedure
Method Regression, Cox
Comments cox regression model used to estimate the HR of death compared to NABTT historical control same histology, adjusted for age, KPS, surgical procedure
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.6 to 1.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 6months -Progression-free Survival Rate
Hide Description defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up
Time Frame At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study

erlotinib hydrochloride: 150mg Given orally once daily

sorafenib tosylate: 400mg Given orally twice daily

pharmacological study: Correlative studies

Overall Number of Participants Analyzed 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14
(8 to 28)
Time Frame events collected from first day of dosing till off treatment - approximately 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description

Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study

erlotinib hydrochloride: 150mg Given orally once daily

sorafenib tosylate: 400mg Given orally twice daily

pharmacological study: Correlative studies

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   0/56 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment
Affected / at Risk (%) # Events
Total   9/56 (16.07%)    
General disorders   
fatigue *  5/56 (8.93%)  5
Investigations   
lipase increased *  4/56 (7.14%)  4
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Peereboom, MD
Organization: Adult Brain Tumor Consortium
Phone: 216-445-6068
EMail: peerebd@ccf.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00445588    
Other Study ID Numbers: NCI-2012-03018
NCI-2012-03018 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR531731
NABTT 0502 ( Other Identifier: New Approaches to Brain Tumor Therapy Consortium )
NABTT-0502 ( Other Identifier: CTEP )
U01CA062475 ( U.S. NIH Grant/Contract )
First Submitted: March 7, 2007
First Posted: March 9, 2007
Results First Submitted: March 25, 2016
Results First Posted: April 27, 2016
Last Update Posted: April 27, 2016