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

Not Recruiting

Trial ID: NCT01032070

Purpose

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.

Official Title

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

Stanford Investigator(s)

Paul Graham Fisher, MD
Paul Graham Fisher, MD

Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health

Eligibility


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

   - 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

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 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

Intervention(s):

drug: Etoposide

drug: Erlotinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535

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