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

Stopped early · Phase 2

Conditions studied: Ependymoma

In brief

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.

Key facts

Study ID

NCT01247922

Run by

OSI Pharmaceuticals

People needed

4

Starts

2011-05-23

Expected to finish

2012-09-13

Last updated by the study team

2024-12-06

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Children's Hospital of Orange County (CHOC) — Orange, California, United States
• Packard Children's Hospital — Palo Alto, California, United States
• The Children's Hospital Center for Cancer and Blood Disorders — Aurora, Colorado, United States
• Children's National Medical Center -D.C. Center for Cancer and Blood Disorders — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Emory University Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• University of Minnesota - Amplatz Children's Hospital — Minneapolis, Minnesota, United States
• Oregon Health & Sciences University Doernbecher Children's Hospital — Portland, Oregon, United States
• Childrens Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Stollery Children's Hospital — Edmonton, Alberta, Canada
• Children's and Women's Health Center of BC — Vancouver, British Columbia, Canada
• Hospital for Sick Children — Toronto, Ontario, Canada
• Birmingham Children's Hospital Oncology Department — Birmingham, United Kingdom
• Royal Hospital for Sick Children — Glasgow, United Kingdom
• Paediatric Oncology and Haematology Offices, — Leeds, United Kingdom
• Alder Hey Children's NHS Foundation Trust — Liverpool, United Kingdom
• Royal Manchester Children's Hospital Ward 84 — Manchester, United Kingdom
• University of Nottingham — Nottingham, United Kingdom
• Royal Marsden Hospital — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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