NCT00039494|CompletedPhase 2

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

A Pilot and Phase II Study of OSI-774 and Temozolomide in Combination With Radiation Therapy in Glioblastoma Multiforme

National Cancer Institute (NCI)ClinicalTrials.gov

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5 other identifiers

NCI-2009-00640N0177CDR0000069388NCCTG-N0177U10CA025224

Study Type

interventional

Target

171

Locations

1 country

Sites

139

Timeline

RegisteredJan 2003

StartedDec 2002

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

171

participants targeted

Target at P75+ for phase_2

Geographic Reach

1 country

139 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2002

Completed

6 months until next milestone

Study Start

First participant enrolled

December 1, 2002

Completed

2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed

Last Updated

August 2, 2013

Status Verified

August 1, 2013

Enrollment Period

4.6 years

First QC Date

June 6, 2002

Last Update Submit

August 1, 2013

Conditions

Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma

Outcome Measures

Primary Outcomes (2)

Survival
At 52 weeks
Overall survival distribution
The overall survival distribution will be estimated using the method of Kaplan-Meier. The success probability, i.e., 12-month survival percentage, will be estimated as the number of evaluable patients still alive at 366 days divided by the total number of evaluable patients followed for at least 366 days.
From start of study therapy to death due to any cause, up to 15 years

Secondary Outcomes (2)

Time-to-disease progression
From start of study therapy to documentation of disease progression, up to 15 years
Maximum toxicity grade, assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Up to 15 years

Study Arms (1)

Treatment (erlotinib hydrochloride, radiation, temozolomide)

EXPERIMENTAL

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.

Drug: erlotinib hydrochlorideRadiation: 3-dimensional conformal radiation therapyDrug: temozolomide

Interventions

erlotinib hydrochlorideDRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

Treatment (erlotinib hydrochloride, radiation, temozolomide)

3-dimensional conformal radiation therapyRADIATION

Also known as: 3D conformal radiation therapy, 3D-CRT

Treatment (erlotinib hydrochloride, radiation, temozolomide)

temozolomideDRUG

Given orally

Also known as: SCH 52365, Temodal, Temodar, TMZ

Treatment (erlotinib hydrochloride, radiation, temozolomide)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (139)

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Northeast Georgia Cancer Care LLC

Athens, Georgia, 30607, United States

Location

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Saint Anthony Memorial Hospital

Effingham, Illinois, 62401, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex - Hospital

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Garneau, Stewart C MD (UIA Investigator)