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

Stopped early · Phase 2

Conditions studied: Recurrent or Refractory Pediatric Ependymoma

In brief

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.

Key facts

Study ID

NCT01032070

Run by

OSI Pharmaceuticals

People needed

25

Starts

2010-09-27

Expected to finish

2012-11-26

Last updated by the study team

2024-12-12

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Alanine aminotransferase (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

You may not qualify if…

• 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 cytochrome P450 (CYP)3A4 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

Where it is running

• 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
• Amplatz Children's Hospital University of Minnesota Medical Center- Pediatric Hematology Oncology — Minneapolis, Minnesota, United States
• Steven D Hassenfeld Children's Center - New York University — New York, New York, United States
• Columbia University Children's Hospital of New York Presbyterian Child & Adolescent Oncology Center — New York, New York, United States
• Oregon Health & Sciences University Doembecher Children's Hospital — Portland, Oregon, United States
• Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Children's Medical Center, Dallas Center for Cancer and Blood Disorders — Dallas, Texas, United States
• University of Wisconsin Pediatric Hematology/Oncology Department — Madison, Wisconsin, United States
• Strollery Children's Hospital Division of Hematology/Oncology — Edmonton, Alberta, Canada
• Children's and Women's Health Center of BC Division of Hematology/ Oncology/ BMT — Vancouver, British Columbia, Canada
• Hospital for Sick Children — Toronto, Ontario, Canada
• Birmingham Children's Hospital — Birmingham, United Kingdom
• Royal Hospital for Sick Children — Glasgow, United Kingdom
• Paediatric Oncology and Haematology Offices — Leeds, United Kingdom
• Alder Hey Children's NHS Foundation Trust Department of Oncology — Liverpool, United Kingdom

Full record on ClinicalTrials.gov

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