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A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma


Phase 2
1 Year
21 Years
Not Enrolling
Both
Recurrent or Refractory Pediatric Ependymoma

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Trial Information

A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma


This is a phase 2 study involving a 1:1 randomization of 40 patients with recurrent or
refractory pediatric ependymoma who will receive either erlotinib or oral etoposide.


Inclusion Criteria:



- Recurrent of refractory ependymoma or subependymoma

- Performance Status (PS): Lansky >=50% for patients <=10 years of age or Karnofsky
>=50% for patients >10 years of age

- Measurable disease, defined as 1 measurable lesion that can be accurately measured in
2 planes that has not received radiation therapy within 12 weeks

- Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or
radiotherapy

- >=1 year to <=21 years

- Serum creatinine for patients <=5 years in age is <=0.8 mg/dL or Creatinine
Clearance/Glomerular Filtration Rate (GFR) >=70 mL/min/m2

- Serum creatinine for patients >5 and <=10 years in age is <=1.0 mg/dL or Creatinine
Clearance/GFR >=70 mL/min/m2

- Serum creatinine for patients >10 and <=15 years in age is <=1.2 mg/dL or Creatinine
Clearance/GFR >=70 mL/min/m2

- Serum creatinine for patients >15 years in age is <=1.5 mg/dL or Creatinine
Clearance/GFR >=70 mL/min/m2

- Total bilirubin is <=1.5 x upper limit of normal for age

- Serum glutamic pyruvic transminase (SGPT) ALT <= 3 x upper limit of normal

- Absolute neutrophil count > 1000/µL

- Platelet count > 100,000/µL

- Hemoglobin > 8 gm/dL

- Neurologically stable for at least 7 days prior to randomization

- If receiving corticosteroids, patients must be on a stable or decreasing dose for at
least 7 days before randomization

- Patients of reproductive potential must agree to proactive effective contraceptive
measures for the duration of the study and for at least 90 days after completion of
study drug

Exclusion Criteria:

- Previously received epidermal growth factor receptor (EGFR)-targeted therapy

- Previously received oral etoposide

- Received craniospinal radiotherapy within 24 weeks prior to randomization

- Received field radiotherapy to the target lesion within 12 weeks prior to
randomization

- Received symptomatic metastatic disease within 14 days prior to randomization

- Received myelosuppressive chemotherapy within 21 days before randomization

- Received growth factors within 7 days prior to randomization

- Participating in another investigational drug trial

- Received a biologic agent within 7 days prior to randomization

- Received a monoclonal antibody within 28 days prior to randomization

- Taking CYP3A4 or CYP1A2 inhibitors/inducers within 14 days prior to randomization

- Taking proton pump inhibitors within 14 days prior to randomization

- Smoking during treatment

- Pregnant or breast-feeding females

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Description:

The proportion of patients with a best overall response of complete response or partial response

Outcome Time Frame:

At end of study (up to 12 months)

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

OSI-774-205

NCT ID:

NCT01032070

Start Date:

December 2009

Completion Date:

November 2012

Related Keywords:

  • Recurrent or Refractory Pediatric Ependymoma
  • phase 2
  • erlotinib
  • pediatric
  • etoposide
  • ependymoma
  • Ependymoma

Name

Location

Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
University of MiamiMiami, Florida  33136
Penn State Hershey Children's HospitalHershey, Pennsylvania  17033
University of Alabama at Birminghamn Dept. of Pediatric-Hematology/OncologyBirmingham, Alabama  35233
Center for Cancer and Blood Disorders-Phoenix Children's HospitalPhoenix, Arizona  85016
Children's Hospital of Orange County (CHOC)Orange, California  92868
Stanford University and Lucile Packard Children's HospitalPalo Alto, California  94304
Children's HospitalCenter for Cancer and Blood DisordersAurora, Colorado  80045
Children's National Medical Center - D.C. Center for Cancer and Blood DisordersWashington, District of Columbia  20010
Emory UniversityChildren's Healthcare of AtlantaAflac Cancer Center & Blood DisordersAtlanta, Georgia  30322
Johns Hopkins UniversitySchool of MedicineBaltimore, Maryland  21287
Dana-Farber Cancer Institute Department of Pediatric Neuro-oncologyBoston, Massachusetts  02115
Amplatz Children's Hospital Univeristy of Minnesota Medical Center- Pediatric Hematology OncologyMinneapolis, Minnesota  55455
Columbia University Children's Hospital of New York Presbyterian Child & Adolescent Oncology CenterNew York, New York  10032
Steven D Hassenfeld Children's Center - New York UniversityNew York, New York  10016
Oregon Health & Sciences UniversityDoembecher Children's HospitalPortland, Oregon  97124
Children's Medical Center, Dallas Center for Cancer and Blood DisordersDallas, Texas  75235
University of WisconsinPediatric Hematology/Oncology DepartmentMadison, Wisconsin  53705-2275