Trial Outcomes & Findings for Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors (NCT NCT00187486)

Results Overview

Patients were monitored until death

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

66 participants

Primary outcome timeframe

assessment of survival was every 2 months, up to 181 weeks

Results posted on

2017-09-05

Participant Flow

66 patients enrolled from 10/2004 - 2/2006. Patients were enrolled at the UCSF Neuro-Oncology clinic.

Participant milestones

Participant milestones
Measure	Temodar Plus Tarceva Plus Radiotherapy All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
Overall Study STARTED	66
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Temodar Plus Tarceva Plus Radiotherapy All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
Overall Study Protocol Violation	1

Baseline Characteristics

Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Temodar Plus Tarceva Plus Radiotherapy n=66 Participants All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants

PRIMARY outcome

Timeframe: assessment of survival was every 2 months, up to 181 weeks

Population: The analysis was per protocol, and intention to treat. Median overall survival measured from the date of registration was the primary endpoint.

Patients were monitored until death

Outcome measures

Outcome measures
Measure	Temodar Plus Tarceva Plus Radiotherapy n=65 Participants All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
Overall Survival	19 months Interval 3.0 to 42.0

SECONDARY outcome

Timeframe: every 2 months measure by MR imaging, up to 39 months

Progression based on MR imaging using the Modified McDonnald Criteria defined as 25% increase in sum of products of all measured lesions or any new lesion

Outcome measures

Outcome measures
Measure	Temodar Plus Tarceva Plus Radiotherapy n=65 Participants All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
Progression Free Survival	8.2 months Interval 2.0 to 39.0

Adverse Events

Temodar Plus Tarceva Plus Radiotherapy

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Temodar Plus Tarceva Plus Radiotherapy n=66 participants at risk All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
Infections and infestations Infection with unknown ANC - Urinary tract NOS	1.5% 1/66 • Number of events 1
Nervous system disorders Seizure	1.5% 1/66 • Number of events 1

Other adverse events

Other adverse events
Measure	Temodar Plus Tarceva Plus Radiotherapy n=66 participants at risk All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
Gastrointestinal disorders Abdominal pain	1.5% 1/66 • Number of events 1
Psychiatric disorders Agitation	1.5% 1/66 • Number of events 1
Infections and infestations Bone infection NOS	1.5% 1/66 • Number of events 1
Psychiatric disorders Cognitive disturbance	1.5% 1/66 • Number of events 1

Additional Information

Michael Prados, MD

University of California San Francisco

Phone: 415 353 2076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place