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

• Status: Terminated
• Trial end date: 2012-11-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OSI Pharmaceuticals
• Treatments: Erlotinib Hydrochloride; Etoposide; Etoposide phosphate

Criteria

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