Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205

Not Recruiting

Trial ID: NCT01247922

Purpose

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.

Official Title

Open-label Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205

Stanford Investigator(s)

Paul Graham Fisher, MD
Paul Graham Fisher, MD

Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health

Eligibility


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers ≤ 14 days before
   registration

   - Have received any other chemotherapy or immunotherapy to treat ependymoma after
   discontinuation from OSI-774-205

   - Taking proton pump inhibitors ≤ 14 days before registration

   - Participating in another investigational drug trial while on study

   - Pregnant or breast-feeding

Intervention(s):

drug: Erlotinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535

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