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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Survival

Outcome Time Frame:

At 52 weeks

Safety Issue:

No

Principal Investigator

Paul Brown

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00640

NCT ID:

NCT00039494

Start Date:

December 2002

Completion Date:

Related Keywords:

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

Name

Location

Mayo ClinicRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
Meeker County Memorial HospitalLichfield, Minnesota  55355
CentraCare ClinicSaint Cloud, Minnesota  56303
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Via Christi Regional Medical CenterWichita, Kansas  67214
Wesley Medical CenterWichita, Kansas  67214
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Welch Cancer CenterSheridan, Wyoming  82801
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Valley Cancer CenterSpring Valley, Illinois  61362
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Bryan LGH Medical Center WestLincoln, Nebraska  68502
Bismarck Cancer CenterBismarck, North Dakota  58501
Eureka HospitalEureka, Illinois  61530
Graham Hospital AssociationCanton, Illinois  61520
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Saint Anthony Regional HospitalCarroll, Iowa  51401
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Community Memorial HospitalMissouri Valley, Iowa  51555-1199
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Fremont Area Medical CenterFremont, Nebraska  68025-2387
Bryan LGH Medical Center EastLincoln, Nebraska  68506
Alegent Health Mercy HospitalCouncil Bluffs, Iowa  51503
Hospital District Sixth of Harper CountyAnthony, Kansas  67003
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
University of VirginiaCharlottesville, Virginia  22908
Woodwinds Health CampusWoodbury, Minnesota  55125
Mid Dakota ClinicBismarck, North Dakota  58501
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Montana Cancer SpecialistsMissoula, Montana  59807-7877
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Rush - Copley Medical CenterAurora, Illinois  60504
Saint Anthony Memorial HospitalEffingham, Illinois  62401
Intercommunity Cancer CenterGalesburg, Illinois  61401
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
Joliet Oncology-Hematology Associates LimitedJoliet, 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 FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Saint Margaret's HospitalSpring Valley, Illinois  61362
Carle Clinic-Urbana MainUrbana, Illinois  61801
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
McFarland ClinicAmes, Iowa  50010
Constantinou, Costas L MD (UIA Investigator)Bettendorf, Iowa  52722
Cedar Rapids Oncology AssociationCedar Rapids, Iowa  52403
Mercy HospitalCedar Rapids, Iowa  52403
Saint Luke's HospitalCedar Rapids, Iowa  52402
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Harris, John Gilbert MD (UIA Investigator)Alexandria, Minnesota  56308
Medini, Eitan MD (UIA Investigator)Alexandria, Minnesota  56308
Brainerd Medical Center IncBrainerd, Minnesota  56401
Miller-Dwan HospitalDuluth, Minnesota  55805
Etzell, Paul S MD (UIA Investigator)Fergus Falls, Minnesota  56537
Swenson, Wade II, MD (UIA Investigator)Fergus Falls, Minnesota  56537
Saint Cloud HospitalSaint Cloud, Minnesota  56303
Saint Joseph's Hospital - HealtheastSaint Paul, Minnesota  55102
Adult and Pediatric Urology PLLPSartell, Minnesota  56377
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Deaconess Medical CenterBillings, Montana  59107
Billings ClinicBillings, Montana  59107-7000
Internal Medicine of BozemanBozeman, Montana  59715
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Saint Elizabeth Regional Medical CenterLincoln, Nebraska  68510
Midlands Community HospitalPapillion, Nebraska  68046
Saint Alexius Medical CenterBismarck, North Dakota  58501
Northeast Georgia Cancer Care LLCAthens, Georgia  30607
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Oncology Associates at Mercy Medical CenterCedar Rapids, Iowa  52403
Sanford Clinic North-FargoFargo, North Dakota  58102
Sanford Medical Center-FargoFargo, North Dakota  58122
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Sanford Clinic North-BemidgiBemidji, Minnesota  56601
Essentia Health Saint Joseph's Medical CenterBrainerd, Minnesota  56401
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Essentia Health Saint Mary's Medical CenterDuluth, Minnesota  55805
Sanford Bismarck Medical CenterBismarck, North Dakota  58501