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U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II


OBJECTIVES:

- Determine response (confirmed, complete, and partial) in patients with unresectable or
metastatic malignant peripheral nerve sheath tumor when treated with erlotinib.

- Determine the qualitative and quantitative toxic effects of this drug in these
patients.

- Correlate, preliminarily, indicators of epidermal growth factor receptor (EGFR)
function (e.g., expression, phosphorylation, or markers of signal transduction
downstream of EGFR) with response and progression-free and overall survival in patients
treated with this drug.

- Determine the feasibility of accruing these patients in the cooperative group setting.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

Patients who achieve at least a confirmed partial response and become resectable undergo
surgical resection (with or without radiotherapy) and then receive 2 additional courses of
erlotinib. Patients with responding disease who do not become resectable continue erlotinib
as above. Patients achieving a complete response (CR) receive 2 additional courses of
erlotinib beyond the CR.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed malignant peripheral nerve sheath tumor

- Malignant schwannoma or neurofibrosarcoma

- Clinical evidence of unresectable or metastatic disease

- Measurable disease

- No known current CNS metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT less than 1.5 times ULN (5 times ULN for patients with documented liver
metastases)

Renal

- Creatinine no greater than 1.5 times ULN

- Creatinine clearance greater than 60 mL/min

Ophthalmic

- No known history of any of the following corneal diseases:

- Dry eye syndrome

- Sjögren's syndrome

- Keratoconjunctivitis sicca

- Exposure keratopathy

- Fuch's dystrophy

- No other active disorders of the cornea

Gastrointestinal

- No gastrointestinal tract disease resulting in an inability to take oral medication
or a requirement for IV alimentation

- No active peptic ulcer disease

- No intractable nausea or vomiting

- Able to swallow medications OR receive enteral medications via gastrostomy feeding
tube

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 28 days since prior biologic therapy for this malignancy

Chemotherapy

- More than 28 days since prior chemotherapy for this malignancy

Endocrine therapy

- Not specified

Radiotherapy

- More than 60 days since prior radiotherapy to the target lesion with subsequent
documented progression

- More than 60 days since prior radiofrequency ablation to the target lesion with
subsequent documented progression

- No concurrent radiotherapy

Surgery

- At least 3 weeks since prior major surgery and recovered

- No prior surgical procedure affecting absorption

Other

- More than 28 days since prior investigational drugs for this malignancy

- More than 60 days since prior embolization to the target lesion with subsequent
documented progression

- No prior epidermal growth factor receptor-targeting therapy

- No concurrent antiretroviral therapy for HIV-positive patients

- No other concurrent investigational or commercial agents or therapies for the
malignancy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor response as assessed by RECIST radiographic criteria

Outcome Description:

x-rays and scans

Outcome Time Frame:

every eight weeks during treatment

Safety Issue:

No

Principal Investigator

Karen H. Albritton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000322023

NCT ID:

NCT00068367

Start Date:

December 2003

Completion Date:

August 2009

Related Keywords:

  • Sarcoma
  • adult neurofibrosarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Nerve Sheath Neoplasms
  • Neurofibrosarcoma
  • Neurilemmoma
  • Sarcoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - NorthwestTacoma, Washington  98405-0986
University of California Davis Cancer CenterSacramento, California  95817
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Spectrum Health Cancer Care - Butterworth CampusGrand Rapids, Michigan  49503-2560
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Mecosta County General HospitalBig Rapids, Michigan  49307
Metropolitan HospitalGrand Rapids, Michigan  49506
Lacks Cancer Center at Saint Mary's Mercy Medical CenterGrand Rapids, Michigan  49503
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Northern Michigan HospitalPetoskey, Michigan  49770
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Central Washington HospitalWenatchee, Washington  98801
Wenatchee Valley ClinicWenatchee, Washington  98801
Welch Cancer CenterSheridan, Wyoming  82801
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Wilson Medical CenterWilson, North Carolina  27893-3428
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Cleveland Clinic - WoosterWooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Danville Regional Medical CenterDanville, Virginia  24541
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
St. Anthony Central HospitalDenver, Colorado  80204-1335
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
St. Anthony North HospitalWestminster, Colorado  80030
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Baton Rouge General Regional Cancer CenterBaton Rouge, Louisiana  70821
Community Oncology Group - IndependenceIndependence, Ohio  44131
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Capital Medical CenterOlympia, Washington  98502
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
St. Joseph Medical Center at Franciscan Health SystemTacoma, Washington  98405-3004
Allenmore HospitalTacoma, Washington  98411-0414
McFarland Clinic, P.C.Ames, Iowa  50010
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
Spectrum Health Hospital - Blodgett CampusGrand Rapids, Michigan  49506
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical CenterPortland, Oregon  97210
Institute of Oncology at Vilnius UniversityPortland, Oregon  97227
Community Comprehensive Cancer Center at Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Auburn Regional Center for Cancer CareAuburn, Washington  98002
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Regional Cancer Center at Providence HospitalCentralia, Washington  98531