Clinical trial · Interventional
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
NCT01032070CI-TRIAL-00083667PETEYterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, it has been stopped.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Refractory Pediatric Ependymoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erlotinib
- 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.
- interventionNames
- Drug: erlotinib
- type
- ACTIVE_COMPARATOR
- label
- Etoposide
- 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.
- interventionNames
- Drug: etoposide
Primary outcomes (1)
- measure
- Percentage of Participants With an Objective Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.