search
Back to results

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

Primary Purpose

Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
3-dimensional conformal radiation therapy
temozolomide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Giant Cell Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mobile Infirmary Medical Center
  • Mayo Clinic in Arizona
  • Mayo Clinic in Florida
  • Northeast Georgia Cancer Care LLC
  • Rush - Copley Medical Center
  • Saint Joseph Medical Center
  • Graham Hospital Association
  • Memorial Hospital
  • Saint Anthony Memorial Hospital
  • Eureka Hospital
  • Galesburg Cottage Hospital
  • Illinois CancerCare Galesburg
  • Western Illinois Cancer Treatment Center
  • Mason District Hospital
  • Hopedale Medical Complex - Hospital
  • Joliet Oncology-Hematology Associates Limited
  • Kewanee Hospital
  • Mcdonough District Hospital
  • Garneau, Stewart C MD (UIA Investigator)
  • Porubcin, Michael MD (UIA Investigator)
  • Sharis, Christine M MD (UIA Investigator)
  • Stoffel, Thomas J MD (UIA Investigator)
  • Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
  • Bromenn Regional Medical Center
  • Community Cancer Center Foundation
  • Illinois CancerCare-Ottawa Clinic
  • Ottawa Regional Hospital and Healthcare Center
  • Pekin Cancer Treatment Center
  • Pekin Hospital
  • Methodist Medical Center of Illinois
  • Proctor Hospital
  • Illinois CancerCare-Peoria
  • Illinois Oncology Research Association CCOP
  • OSF Saint Francis Medical Center
  • Illinois Valley Hospital
  • Perry Memorial Hospital
  • Saint Margaret's Hospital
  • Valley Cancer Center
  • Carle Clinic-Urbana Main
  • Saint Anthony Memorial Health Center
  • McFarland Clinic
  • Constantinou, Costas L MD (UIA Investigator)
  • Saint Anthony Regional Hospital
  • Saint Luke's Hospital
  • Cedar Rapids Oncology Association
  • Mercy Hospital
  • Oncology Associates at Mercy Medical Center
  • Medical Oncology and Hematology Associates-West Des Moines
  • Alegent Health Mercy Hospital
  • Mercy Capitol
  • Iowa Methodist Medical Center
  • Iowa Oncology Research Association CCOP
  • Medical Oncology and Hematology Associates-Des Moines
  • Medical Oncology and Hematology Associates
  • Mercy Medical Center - Des Moines
  • Iowa Lutheran Hospital
  • Community Memorial Hospital
  • Burgess Memorial Hospital
  • Siouxland Regional Cancer Center
  • Siouxland Hematology Oncology Associates
  • Mercy Medical Center-Sioux City
  • Saint Luke's Regional Medical Center
  • Hospital District Sixth of Harper County
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas-Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas - Newton
  • Cancer Center of Kansas - Parsons
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Main Office
  • Via Christi Regional Medical Center
  • Wesley Medical Center
  • Wichita CCOP
  • Cancer Center of Kansas - Winfield
  • Saint Joseph Mercy Hospital
  • Michigan Cancer Research Consortium Community Clinical Oncology Program
  • Oakwood Hospital
  • Saint John Hospital and Medical Center
  • Hurley Medical Center
  • Genesys Regional Medical Center-West Flint Campus
  • Allegiance Health
  • Sparrow Hospital
  • Saint Mary's of Michigan
  • Saint John Macomb-Oakland Hospital
  • Harris, John Gilbert MD (UIA Investigator)
  • Medini, Eitan MD (UIA Investigator)
  • Sanford Clinic North-Bemidgi
  • Brainerd Medical Center Inc
  • Essentia Health Saint Joseph's Medical Center
  • Essentia Health Duluth Clinic CCOP
  • Essentia Health Saint Mary's Medical Center
  • Miller-Dwan Hospital
  • Etzell, Paul S MD (UIA Investigator)
  • Swenson, Wade II, MD (UIA Investigator)
  • Meeker County Memorial Hospital
  • Virginia Piper Cancer Institute
  • Chippewa County - Montevideo Hospital
  • Mayo Clinic
  • CentraCare Clinic
  • Saint Cloud Hospital
  • Saint Joseph's Hospital - Healtheast
  • Adult and Pediatric Urology PLLP
  • Woodwinds Health Campus
  • Montana Cancer Consortium CCOP
  • Northern Rockies Radiation Oncology Center
  • Saint Vincent Healthcare
  • Hematology-Oncology Centers of the Northern Rockies PC
  • Billings Clinic
  • Deaconess Medical Center
  • Bozeman Deaconess Cancer Center
  • Bozeman Deaconess Hospital
  • Internal Medicine of Bozeman
  • Saint James Community Hospital and Cancer Treatment Center
  • Saint Peter's Community Hospital
  • Glacier Oncology PLLC
  • Community Medical Hospital
  • Montana Cancer Specialists
  • Saint Patrick Hospital - Community Hospital
  • Fremont Area Medical Center
  • Bryan LGH Medical Center West
  • Bryan LGH Medical Center East
  • Saint Elizabeth Regional Medical Center
  • Midlands Community Hospital
  • Bismarck Cancer Center
  • Mid Dakota Clinic
  • Saint Alexius Medical Center
  • Sanford Bismarck Medical Center
  • Sanford Clinic North-Fargo
  • Sanford Medical Center-Fargo
  • University of Virginia
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (erlotinib hydrochloride, radiation, temozolomide)

Arm Description

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.

Outcomes

Primary Outcome Measures

Survival
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.

Secondary Outcome Measures

Time-to-disease progression
The time-to-progression distribution will be estimated using the Kaplan-Meier method.
Maximum toxicity grade, assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Frequency tables will be reviewed to determine toxicity patterns.

Full Information

First Posted
June 6, 2002
Last Updated
August 1, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00039494
Brief Title
Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors
Official Title
A Pilot and Phase II Study of OSI-774 and Temozolomide in Combination With Radiation Therapy in Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
171 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (erlotinib hydrochloride, radiation, temozolomide)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
CP-358,774, erlotinib, OSI-774
Intervention Description
Given orally
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Other Intervention Name(s)
3D conformal radiation therapy, 3D-CRT
Intervention Type
Drug
Intervention Name(s)
temozolomide
Other Intervention Name(s)
SCH 52365, Temodal, Temodar, TMZ
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Survival
Time Frame
At 52 weeks
Title
Overall survival distribution
Description
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.
Time Frame
From start of study therapy to death due to any cause, up to 15 years
Secondary Outcome Measure Information:
Title
Time-to-disease progression
Description
The time-to-progression distribution will be estimated using the Kaplan-Meier method.
Time Frame
From start of study therapy to documentation of disease progression, up to 15 years
Title
Maximum toxicity grade, assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Description
Frequency tables will be reviewed to determine toxicity patterns.
Time Frame
Up to 15 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Brown
Organizational Affiliation
North Central Cancer Treatment Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Facility Name
Northeast Georgia Cancer Care LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Saint Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital Association
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Saint Anthony Memorial Hospital
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Eureka Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Western Illinois Cancer Treatment Center
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Hopedale Medical Complex - Hospital
City
Hopedale
State/Province
Illinois
ZIP/Postal Code
61747
Country
United States
Facility Name
Joliet Oncology-Hematology Associates Limited
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Kewanee Hospital
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Mcdonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Garneau, Stewart C MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Porubcin, Michael MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Sharis, Christine M MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Stoffel, Thomas J MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Bromenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center Foundation
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Ottawa Regional Hospital and Healthcare Center
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Pekin Cancer Treatment Center
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Illinois Oncology Research Association CCOP
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois Valley Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Saint Margaret's Hospital
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Valley Cancer Center
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Carle Clinic-Urbana Main
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Saint Anthony Memorial Health Center
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Constantinou, Costas L MD (UIA Investigator)
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Saint Anthony Regional Hospital
City
Carroll
State/Province
Iowa
ZIP/Postal Code
51401
Country
United States
Facility Name
Saint Luke's Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52402
Country
United States
Facility Name
Cedar Rapids Oncology Association
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Oncology Associates at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Alegent Health Mercy Hospital
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Mercy Capitol
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50307
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Iowa Oncology Research Association CCOP
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
Community Memorial Hospital
City
Missouri Valley
State/Province
Iowa
ZIP/Postal Code
51555
Country
United States
Facility Name
Burgess Memorial Hospital
City
Onawa
State/Province
Iowa
ZIP/Postal Code
51040
Country
United States
Facility Name
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
Siouxland Hematology Oncology Associates
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center-Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Saint Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Hospital District Sixth of Harper County
City
Anthony
State/Province
Kansas
ZIP/Postal Code
67003
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas - Main Office
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wichita CCOP
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
Michigan Cancer Research Consortium Community Clinical Oncology Program
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Hospital
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Saint John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Facility Name
Genesys Regional Medical Center-West Flint Campus
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Saint Mary's of Michigan
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Harris, John Gilbert MD (UIA Investigator)
City
Alexandria
State/Province
Minnesota
ZIP/Postal Code
56308
Country
United States
Facility Name
Medini, Eitan MD (UIA Investigator)
City
Alexandria
State/Province
Minnesota
ZIP/Postal Code
56308
Country
United States
Facility Name
Sanford Clinic North-Bemidgi
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Brainerd Medical Center Inc
City
Brainerd
State/Province
Minnesota
ZIP/Postal Code
56401
Country
United States
Facility Name
Essentia Health Saint Joseph's Medical Center
City
Brainerd
State/Province
Minnesota
ZIP/Postal Code
56401
Country
United States
Facility Name
Essentia Health Duluth Clinic CCOP
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Essentia Health Saint Mary's Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller-Dwan Hospital
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Etzell, Paul S MD (UIA Investigator)
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
Swenson, Wade II, MD (UIA Investigator)
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
Meeker County Memorial Hospital
City
Litchfield
State/Province
Minnesota
ZIP/Postal Code
55355
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Chippewa County - Montevideo Hospital
City
Montevideo
State/Province
Minnesota
ZIP/Postal Code
56265
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CentraCare Clinic
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Saint Cloud Hospital
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Saint Joseph's Hospital - Healtheast
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Adult and Pediatric Urology PLLP
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
Woodwinds Health Campus
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Montana Cancer Consortium CCOP
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Saint Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies PC
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Deaconess Medical Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Internal Medicine of Bozeman
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Saint James Community Hospital and Cancer Treatment Center
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Montana Cancer Specialists
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Fremont Area Medical Center
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Bryan LGH Medical Center West
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
Facility Name
Bryan LGH Medical Center East
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Saint Elizabeth Regional Medical Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Midlands Community Hospital
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Bismarck Cancer Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Mid Dakota Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Saint Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Sanford Clinic North-Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Medical Center-Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18955445
Citation
Brown PD, Krishnan S, Sarkaria JN, Wu W, Jaeckle KA, Uhm JH, Geoffroy FJ, Arusell R, Kitange G, Jenkins RB, Kugler JW, Morton RF, Rowland KM Jr, Mischel P, Yong WH, Scheithauer BW, Schiff D, Giannini C, Buckner JC; North Central Cancer Treatment Group Study N0177. Phase I/II trial of erlotinib and temozolomide with radiation therapy in the treatment of newly diagnosed glioblastoma multiforme: North Central Cancer Treatment Group Study N0177. J Clin Oncol. 2008 Dec 1;26(34):5603-9. doi: 10.1200/JCO.2008.18.0612. Epub 2008 Oct 27.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs