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NCT00039494

Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Brief Summary

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This pilot phase II trial is studying the side effects and best dose of erlotinib when given with temozolomide and radiation therapy and to see how well they work in treating patients with glioblastoma multiforme or other brain tumors. Radiation therapy uses high-energy x-rays to damage tumor cells. Erlotinib may interfere with the growth of tumor cells, slow the growth of the tumor, and make the tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and temozolomide with radiation therapy may kill more tumor cells.

Detailed Description

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PILOT STUDY OBJECTIVES:

I. Determine the maximum tolerated dose of erlotinib administered with temozolomide and radiotherapy in patients with glioblastoma multiforme or other grade 4 brain tumors who are currently on enzyme-inducing anticonvulsant (EIAC) therapy vs no EIAC therapy.

II. Determine the safety and tolerability of this regimen in these patients. III. Determine the toxic effects of this regimen in these patients. IV. Determine the efficacy of this regimen, in terms of 1-year survival, in these patients.

PHASE II OBJECTIVES:

I. Determine the response rate and time to progression in patients treated with this regimen.

II. Determine the 6-month progression-free survival of patients treated with this regimen.

III. Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation pilot study of erlotinib followed by a phase II study. Patients are stratified according to concurrent enzyme-inducing anticonvulsant drug use (yes vs no).

PILOT STUDY: Patients receive oral erlotinib once daily. After 1 week of erlotinib alone, patients also receive oral temozolomide once daily for 6 weeks and undergo concurrent radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients continue to receive erlotinib once daily alone in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of radiotherapy, patients also receive oral temozolomide once daily for 5 days. Temozolomide treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PHASE II: Once the MTD of erlotinib is determined, additional patients are treated with erlotinib at the MTD, temozolomide, and radiotherapy as above.

Patients are followed every 3 months for 5 years and then annually for 10 years.

Conditions

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Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (erlotinib hydrochloride, radiation, temozolomide)

Patients receive oral erlotinib once daily. After 1 week of erlotinib alone, patients also receive oral temozolomide once daily for 6 weeks and undergo concurrent radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients continue to receive erlotinib once daily alone in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of radiotherapy, patients also receive oral temozolomide once daily for 5 days. Temozolomide treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

erlotinib hydrochloride

Intervention Type DRUG

Given orally

3-dimensional conformal radiation therapy

Intervention Type RADIATION

temozolomide

Intervention Type DRUG

Given orally

Interventions

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erlotinib hydrochloride

Given orally

Intervention Type DRUG

3-dimensional conformal radiation therapy

Intervention Type RADIATION

temozolomide

Given orally

Intervention Type DRUG

Other Intervention Names

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CP-358,774 erlotinib OSI-774 3D conformal radiation therapy 3D-CRT SCH 52365 Temodal Temodar TMZ

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of 1 of the following:

* Glioblastoma multiforme (grade 4 astrocytoma)
* Gliosarcomas
* Other grade 4 astrocytoma variants (e.g., giant cell)
* Must be enrolled at least 1 week, but no more than 4 weeks, after prior biopsy or surgery
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* At least 6 months
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* Creatinine no greater than 1.5 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No inability to take oral medications
* No requirement for IV alimentation
* No active uncontrolled peptic ulcer disease
* No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
* No congenital abnormality (e.g., Fuch's dystrophy)
* No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
* No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
* No prior allergy or intolerance to dacarbazine
* No other active malignancy requiring treatment
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy for any brain tumor
* No prior temozolomide
* No prior radiotherapy for any brain tumor
* No other concurrent investigational agents
* More than 21 days since prior major surgery (excluding neurosurgical biopsy or brain tumor resection)
* No prior surgical procedures affecting absorption
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent warfarin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Brown

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

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Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Northeast Georgia Cancer Care LLC

Athens, Georgia, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Saint Anthony Memorial Hospital

Effingham, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare Galesburg

Galesburg, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex - Hospital

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Sharis, Christine M MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Stoffel, Thomas J MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Vigliotti, Antonio, P.G. M.D. (UIA Investigator)

Moline, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Illinois Oncology Research Association CCOP

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Valley Cancer Center

Spring Valley, Illinois, United States

Site Status

Carle Clinic-Urbana Main

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Center

Michigan City, Indiana, United States

Site Status

McFarland Clinic

Ames, Iowa, United States

Site Status

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

Site Status

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Site Status

Saint Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Cedar Rapids Oncology Association

Cedar Rapids, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status