Clinical trial NCT01247922: Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ependymoma
Keywords: Pediatric Ependymoma
Ependymoma
Tarceva
Erlotinib
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-11-25
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
timeFrame: From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)
Secondary outcomes:
measure: Best Overall Response
timeFrame: End of treatment (The mean treatment duration was 170.5 days.)
measure: Median Treatment Duration
timeFrame: From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Orange
country: United States
facility: Children's Hospital of Orange County (CHOC)
state: California
city: Palo Alto
country: United States
facility: Packard Children's Hospital
state: California
city: Aurora
country: United States
facility: The Children's Hospital Center for Cancer and Blood Disorders
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center -D.C. Center for Cancer and Blood Disorders
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University Children's Healthcare of Atlanta
state: Georgia
city: Minneapolis
country: United States
facility: University of Minnesota - Amplatz Children's Hospital
state: Minnesota
city: Portland
country: United States
facility: Oregon Health & Sciences University Doernbecher Children's Hospital
state: Oregon
city: Pittsburgh
country: United States
facility: Childrens Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Children's and Women's Health Center of BC
state: British Columbia
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital Oncology Department
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
city: Leeds
country: United Kingdom
facility: Paediatric Oncology and Haematology Offices,
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital Ward 84
city: Nottingham
country: United Kingdom
facility: University of Nottingham
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Monitor
role: STUDY_DIRECTOR
References: