Open-label, Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205
Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Erlotinib
Phase: Phase 2
Ages Eligible For Study:
- Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide - Performance status: Lansky ? 50% for patients ? 10 years of age or younger or Karnofsky ? 50% for patients greater than 10 years of age - Patients must have recovered from any acute toxicity to any prior anti-cancer treatment - Total bilirubin ? 1.5 x upper limit of normal (ULN) for age, serum glutamic pyruvic transaminase (SGPT) ALT ? 3 x ULN - Serum creatinine based on age OR Creatinine Clearance/Glomerular Filtration Rate (GFR) ? 70 mL/min/m2 - Patients must be neurologically stable for at least 7 days before registration - Patients, both males and females, with reproductive potential must agree to practice effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study drug therapy - Patients must be able to take erlotinib orally