A Phase I/II Study of OSI-774 and Temozolomide In Combination With Radiation Therapy In Glioblastoma Multiforme
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival
At 52 weeks
No
Paul Brown
Principal Investigator
North Central Cancer Treatment Group
United States: Food and Drug Administration
NCI-2009-00640
NCT00039494
December 2002
Name | Location |
---|---|
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 |