Trial Search Results

Single-agent Erlotinib in Patients 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 currently not accepting patients for this trial.

Lead Sponsor:

OSI Pharmaceuticals

Stanford Investigator(s):


  • Drug: Erlotinib


Phase 2


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

   - 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

   - 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

Ages Eligible for Study

1 Year - 21 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
Not Recruiting