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

OSI Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Recurrent or Refractory Pediatric Ependymoma

Treatments: Drug: etoposide; Drug: erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01032070

OSI-774-205

2009-016836-11 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Erlotinib

Experimental group

Description:

Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.

Treatment:

Drug: erlotinib

Etoposide

Active Comparator group

Description:

Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.

Treatment:

Drug: etoposide