Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma

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

NCT01032070•OSI Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.

Detailed Description

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.

Eligibility

Age

1 - 21 years

Sex

ALL

Healthy Volunteers

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/m\^2
•Serum creatinine for patients \> 5 and ≤ 10 years in age is ≤ 1.0 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m\^2
•Serum creatinine for patients \> 10 and ≤ 15 years in age is ≤ 1.2 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m\^2
•Serum creatinine for patients \> 15 years in age is ≤ 1.5 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m\^2
•Total bilirubin is ≤ 1.5 x upper limit of normal for age
+7 more criteria

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
+4 more criteria

Locations (28)

University of Alabama at Birmingham Dept. of Pediatric-Hematology/Oncology

Birmingham, Alabama, United States

Center for Cancer and Blood Disorders-Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital of Orange County (CHOC)

Orange, California, United States

Stanford University and Lucile Packard Children's Hospital

Palo Alto, California, United States

Children's Hospital Center for Cancer and Blood Disorders

Aurora, Colorado, United States

Children's National Medical Center - D.C. Center for Cancer and Blood Disorders

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

Emory University Children's Healthcare of Atlanta Aflac Cancer Center & Blood Disorders

Atlanta, Georgia, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Dana-Farber Cancer Institute Department of Pediatric Neuro-oncology

Boston, Massachusetts, United States

Key Dates

Start Date

September 27, 2010

Primary Completion Date

November 26, 2012

Completion Date

November 26, 2012

Last Updated

December 12, 2024

Enrollment

ACTUAL participants

Conditions

Recurrent or Refractory Pediatric Ependymoma

Interventions

erlotinib

DRUG

etoposide

DRUG