Know Cancer

forgot password

A Phase I/II Study of OSI-774 and Temozolomide In Combination With Radiation Therapy In Glioblastoma Multiforme

Phase 2
18 Years
Open (Enrolling)
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

Thank you

Trial Information

A Phase I/II Study of OSI-774 and Temozolomide In Combination With Radiation Therapy In Glioblastoma Multiforme


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.


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

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.

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

- 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

- No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

At 52 weeks

Safety Issue:


Principal Investigator

Paul Brown

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2002

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Glioblastoma
  • Gliosarcoma



Mayo Clinic Rochester, Minnesota  55905
Hurley Medical Center Flint, Michigan  48503
Meeker County Memorial Hospital Lichfield, Minnesota  55355
CentraCare Clinic Saint Cloud, Minnesota  56303
Methodist Medical Center of Illinois Peoria, Illinois  61636
Virginia Piper Cancer Institute Minneapolis, Minnesota  55407
Via Christi Regional Medical Center Wichita, Kansas  67214
Wesley Medical Center Wichita, Kansas  67214
Iowa Methodist Medical Center Des Moines, Iowa  50309
Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Cancer Center of Kansas - Chanute Chanute, Kansas  66720
Cancer Center of Kansas - Dodge City Dodge City, Kansas  67801
Cancer Center of Kansas - Newton Newton, Kansas  67114
Cancer Center of Kansas - Salina Salina, Kansas  67042
Cancer Center of Kansas - Wellington Wellington, Kansas  67152
Associates in Womens Health Wichita, Kansas  67203
Cancer Center of Kansas - Winfield Winfield, Kansas  67156
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
Welch Cancer Center Sheridan, Wyoming  82801
Memorial Hospital Carthage, Illinois  62321
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Kewanee Hospital Kewanee, Illinois  61443
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Proctor Hospital Peoria, Illinois  61614
Perry Memorial Hospital Princeton, Illinois  61356
Valley Cancer Center Spring Valley, Illinois  61362
Chippewa County - Montevideo Hospital Montevideo, Minnesota  56265
Bryan LGH Medical Center West Lincoln, Nebraska  68502
Bismarck Cancer Center Bismarck, North Dakota  58501
Eureka Hospital Eureka, Illinois  61530
Graham Hospital Association Canton, Illinois  61520
Saint Joseph Medical Center Joliet, Illinois  60435
Pekin Hospital Pekin, Illinois  61554
Saint Anthony Regional Hospital Carroll, Iowa  51401
Medical Oncology and Hematology Associates Des Moines, Iowa  50309
Community Memorial Hospital Missouri Valley, Iowa  51555-1199
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fremont Area Medical Center Fremont, Nebraska  68025-2387
Bryan LGH Medical Center East Lincoln, Nebraska  68506
Alegent Health Mercy Hospital Council Bluffs, Iowa  51503
Hospital District Sixth of Harper County Anthony, Kansas  67003
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Lawrence Memorial Hospital Lawrence, Kansas  66044
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224
University of Virginia Charlottesville, Virginia  22908
Woodwinds Health Campus Woodbury, Minnesota  55125
Mid Dakota Clinic Bismarck, North Dakota  58501
Wichita CCOP Wichita, Kansas  67214-3882
Montana Cancer Consortium CCOP Billings, Montana  59101
Montana Cancer Specialists Missoula, Montana  59807-7877
OSF Saint Francis Medical Center Peoria, Illinois  61637
Rush - Copley Medical Center Aurora, Illinois  60504
Saint Anthony Memorial Hospital Effingham, Illinois  62401
Intercommunity Cancer Center Galesburg, Illinois  61401
Hopedale Medical Complex - Hospital Hopedale, Illinois  61747
Joliet Oncology-Hematology Associates Limited Joliet, Illinois  60435
Vigliotti, Antonio, P.G. M.D. (UIA Investigator) Moline, Illinois  61265
Stoffel, Thomas J MD (UIA Investigator) Moline, Illinois  61265
Garneau, Stewart C MD (UIA Investigator) Moline, Illinois  61265
Sharis, Christine M MD (UIA Investigator) Moline, Illinois  61265
Porubcin, Michael MD (UIA Investigator) Moline, Illinois  61265
Community Cancer Center Foundation Normal, Illinois  61761
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois  61350
Ottawa Regional Hospital and Healthcare Center Ottawa, Illinois  61350
Pekin Cancer Treatment Center Pekin, Illinois  61554
Illinois Oncology Research Association CCOP Peoria, Illinois  61615
Illinois CancerCare-Peoria Peoria, Illinois  61615
Illinois Valley Hospital Peru, Illinois  61354
Saint Margaret's Hospital Spring Valley, Illinois  61362
Carle Clinic-Urbana Main Urbana, Illinois  61801
Saint Anthony Memorial Health Center Michigan City, Indiana  46360
McFarland Clinic Ames, Iowa  50010
Constantinou, Costas L MD (UIA Investigator) Bettendorf, Iowa  52722
Cedar Rapids Oncology Association Cedar Rapids, Iowa  52403
Mercy Hospital Cedar Rapids, Iowa  52403
Saint Luke's Hospital Cedar Rapids, Iowa  52402
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa  50325
Iowa Oncology Research Association CCOP Des Moines, Iowa  50309
Mercy Capitol Des Moines, Iowa  50307
Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des Moines Des Moines, Iowa  50309
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Cancer Center of Kansas - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Kingman Kingman, Kansas  67068
Cancer Center of Kansas - Parsons Parsons, Kansas  67357
Cancer Center of Kansas - Pratt Pratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas - Main Office Wichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor, Michigan  48106
Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Allegiance Health Jackson, Michigan  49201
Sparrow Hospital Lansing, Michigan  48912
Saint Mary's of Michigan Saginaw, Michigan  48601
Saint John Macomb-Oakland Hospital Warren, Michigan  48093
Harris, John Gilbert MD (UIA Investigator) Alexandria, Minnesota  56308
Medini, Eitan MD (UIA Investigator) Alexandria, Minnesota  56308
Brainerd Medical Center Inc Brainerd, Minnesota  56401
Miller-Dwan Hospital Duluth, Minnesota  55805
Etzell, Paul S MD (UIA Investigator) Fergus Falls, Minnesota  56537
Swenson, Wade II, MD (UIA Investigator) Fergus Falls, Minnesota  56537
Saint Cloud Hospital Saint Cloud, Minnesota  56303
Saint Joseph's Hospital - Healtheast Saint Paul, Minnesota  55102
Adult and Pediatric Urology PLLP Sartell, Minnesota  56377
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Deaconess Medical Center Billings, Montana  59107
Billings Clinic Billings, Montana  59107-7000
Internal Medicine of Bozeman Bozeman, Montana  59715
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Community Medical Hospital Missoula, Montana  59801
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Saint Elizabeth Regional Medical Center Lincoln, Nebraska  68510
Midlands Community Hospital Papillion, Nebraska  68046
Saint Alexius Medical Center Bismarck, North Dakota  58501
Northeast Georgia Cancer Care LLC Athens, Georgia  30607
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa  52403
Sanford Clinic North-Fargo Fargo, North Dakota  58102
Sanford Medical Center-Fargo Fargo, North Dakota  58122
Genesys Regional Medical Center-West Flint Campus Flint, Michigan  48532
Sanford Clinic North-Bemidgi Bemidji, Minnesota  56601
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota  56401
Essentia Health Duluth Clinic CCOP Duluth, Minnesota  55805
Essentia Health Saint Mary's Medical Center Duluth, Minnesota  55805
Sanford Bismarck Medical Center Bismarck, North Dakota  58501