Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
OSI Pharmaceuticals
The protocol-specified futility criteria were met at the second interim analysis dated 15 Aug 2012 for OSI-774-205. Per the Data Monitoring Committee's recommendation and FDA's agreement, the enrollment of patients in that study and Study OSI-774-206 was permanently closed.
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
