Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma (NCT01032070) | Clinical Trial Compass
TerminatedPhase 2
Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
Stopped: In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, it has been stopped.
United States25 participantsStarted 2010-09-27
Plain-language 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.
Who can participate
Age range1 Year – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 le…
What they're measuring
1
Percentage of Participants With an Objective Response
Timeframe: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.