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Spots Global Cancer Trial Database for Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors

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Trial Identification

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 ID: NCT00039494

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mobile Infirmary Medical Center, Mobile, Alabama, United States

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Mayo Clinic in Florida, Jacksonville, Florida, United States

Northeast Georgia Cancer Care LLC, Athens, Georgia, United States

Rush - Copley Medical Center, Aurora, Illinois, United States

Saint Joseph Medical Center, Bloomington, Illinois, United States

Graham Hospital Association, Canton, Illinois, United States

Memorial Hospital, Carthage, Illinois, United States

Saint Anthony Memorial Hospital, Effingham, Illinois, United States

Eureka Hospital, Eureka, Illinois, United States

Galesburg Cottage Hospital, Galesburg, Illinois, United States

Illinois CancerCare Galesburg, Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States

Mason District Hospital, Havana, Illinois, United States

Hopedale Medical Complex - Hospital, Hopedale, Illinois, United States

Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States

Kewanee Hospital, Kewanee, Illinois, United States

Mcdonough District Hospital, Macomb, Illinois, United States

Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States

Porubcin, Michael MD (UIA Investigator), Moline, Illinois, United States

Sharis, Christine M MD (UIA Investigator), Moline, Illinois, United States

Stoffel, Thomas J MD (UIA Investigator), Moline, Illinois, United States

Vigliotti, Antonio, P.G. M.D. (UIA Investigator), Moline, Illinois, United States

Bromenn Regional Medical Center, Normal, Illinois, United States

Community Cancer Center Foundation, Normal, Illinois, United States

Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States

Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States

Pekin Cancer Treatment Center, Pekin, Illinois, United States

Pekin Hospital, Pekin, Illinois, United States

Methodist Medical Center of Illinois, Peoria, Illinois, United States

Proctor Hospital, Peoria, Illinois, United States

Illinois CancerCare-Peoria, Peoria, Illinois, United States

Illinois Oncology Research Association CCOP, Peoria, Illinois, United States

OSF Saint Francis Medical Center, Peoria, Illinois, United States

Illinois Valley Hospital, Peru, Illinois, United States

Perry Memorial Hospital, Princeton, Illinois, United States

Saint Margaret's Hospital, Spring Valley, Illinois, United States

Valley Cancer Center, Spring Valley, Illinois, United States

Carle Clinic-Urbana Main, Urbana, Illinois, United States

Saint Anthony Memorial Health Center, Michigan City, Indiana, United States

McFarland Clinic, Ames, Iowa, United States

Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States

Saint Anthony Regional Hospital, Carroll, Iowa, United States

Saint Luke's Hospital, Cedar Rapids, Iowa, United States

Cedar Rapids Oncology Association, Cedar Rapids, Iowa, United States

Mercy Hospital, Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States

Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States

Alegent Health Mercy Hospital, Council Bluffs, Iowa, United States

Mercy Capitol, Des Moines, Iowa, United States

Iowa Methodist Medical Center, Des Moines, Iowa, United States

Iowa Oncology Research Association CCOP, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates, Des Moines, Iowa, United States

Mercy Medical Center - Des Moines, Des Moines, Iowa, United States

Iowa Lutheran Hospital, Des Moines, Iowa, United States

Community Memorial Hospital, Missouri Valley, Iowa, United States

Burgess Memorial Hospital, Onawa, Iowa, United States

Siouxland Regional Cancer Center, Sioux City, Iowa, United States

Siouxland Hematology Oncology Associates, Sioux City, Iowa, United States

Mercy Medical Center-Sioux City, Sioux City, Iowa, United States

Saint Luke's Regional Medical Center, Sioux City, Iowa, United States

Hospital District Sixth of Harper County, Anthony, Kansas, United States

Cancer Center of Kansas - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas-Kingman, Kingman, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Cancer Center of Kansas - Newton, Newton, Kansas, United States

Cancer Center of Kansas - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas - Salina, Salina, Kansas, United States

Cancer Center of Kansas - Wellington, Wellington, Kansas, United States

Associates In Womens Health, Wichita, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas - Main Office, Wichita, Kansas, United States

Via Christi Regional Medical Center, Wichita, Kansas, United States

Wesley Medical Center, Wichita, Kansas, United States

Wichita CCOP, Wichita, Kansas, United States

Cancer Center of Kansas - Winfield, Winfield, Kansas, United States

Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States

Michigan Cancer Research Consortium Community Clinical Oncology Program, Ann Arbor, Michigan, United States

Oakwood Hospital, Dearborn, Michigan, United States

Saint John Hospital and Medical Center, Detroit, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States

Allegiance Health, Jackson, Michigan, United States

Sparrow Hospital, Lansing, Michigan, United States

Saint Mary's of Michigan, Saginaw, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, Michigan, United States

Harris, John Gilbert MD (UIA Investigator), Alexandria, Minnesota, United States

Medini, Eitan MD (UIA Investigator), Alexandria, Minnesota, United States

Sanford Clinic North-Bemidgi, Bemidji, Minnesota, United States

Brainerd Medical Center Inc, Brainerd, Minnesota, United States

Essentia Health Saint Joseph's Medical Center, Brainerd, Minnesota, United States

Essentia Health Duluth Clinic CCOP, Duluth, Minnesota, United States

Essentia Health Saint Mary's Medical Center, Duluth, Minnesota, United States

Miller-Dwan Hospital, Duluth, Minnesota, United States

Etzell, Paul S MD (UIA Investigator), Fergus Falls, Minnesota, United States

Swenson, Wade II, MD (UIA Investigator), Fergus Falls, Minnesota, United States

Meeker County Memorial Hospital, Litchfield, Minnesota, United States

Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States

Chippewa County - Montevideo Hospital, Montevideo, Minnesota, United States

Mayo Clinic, Rochester, Minnesota, United States

CentraCare Clinic, Saint Cloud, Minnesota, United States

Saint Cloud Hospital, Saint Cloud, Minnesota, United States

Saint Joseph's Hospital - Healtheast, Saint Paul, Minnesota, United States

Adult and Pediatric Urology PLLP, Sartell, Minnesota, United States

Woodwinds Health Campus, Woodbury, Minnesota, United States

Montana Cancer Consortium CCOP, Billings, Montana, United States

Northern Rockies Radiation Oncology Center, Billings, Montana, United States

Saint Vincent Healthcare, Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies PC, Billings, Montana, United States

Billings Clinic, Billings, Montana, United States

Deaconess Medical Center, Billings, Montana, United States

Bozeman Deaconess Cancer Center, Bozeman, Montana, United States

Bozeman Deaconess Hospital, Bozeman, Montana, United States

Internal Medicine of Bozeman, Bozeman, Montana, United States

Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States

Saint Peter's Community Hospital, Helena, Montana, United States

Glacier Oncology PLLC, Kalispell, Montana, United States

Community Medical Hospital, Missoula, Montana, United States

Montana Cancer Specialists, Missoula, Montana, United States

Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States

Fremont Area Medical Center, Fremont, Nebraska, United States

Bryan LGH Medical Center West, Lincoln, Nebraska, United States

Bryan LGH Medical Center East, Lincoln, Nebraska, United States

Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, United States

Midlands Community Hospital, Papillion, Nebraska, United States

Bismarck Cancer Center, Bismarck, North Dakota, United States

Mid Dakota Clinic, Bismarck, North Dakota, United States

Saint Alexius Medical Center, Bismarck, North Dakota, United States

Sanford Bismarck Medical Center, Bismarck, North Dakota, United States

Sanford Clinic North-Fargo, Fargo, North Dakota, United States

Sanford Medical Center-Fargo, Fargo, North Dakota, United States

University of Virginia, Charlottesville, Virginia, United States

Welch Cancer Center, Sheridan, Wyoming, United States

Contact Details

Name: Paul Brown

Affiliation: North Central Cancer Treatment Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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