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

Conditions

• Recurrent or Refractory Pediatric Ependymoma

Eligibility Criteria

Sex

ALL

Age

1 Year - 21 Years

Healthy Volunteers

Not accepted

Interventions

• erlotinib — DRUG
  oral
• etoposide — DRUG
  oral

Study Details

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.

Key Dates

First listed

Dec 15, 2009

Start date

Sep 27, 2010

Status verified

Nov 2024

Primary completion

Nov 26, 2012

Completion

Nov 26, 2012

Study Design

Enrollment

25 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Erlotinib
  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.
• Active Comparator: Etoposide
  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.

Primary Outcome Measure

Percentage of Participants With an Objective Response [ Time Frame: From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. ]

Locations (18)

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