Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
NCT ID: NCT01032070
Last Updated: 2024-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
25 participants
INTERVENTIONAL
2010-09-27
2012-11-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Erlotinib
Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
erlotinib
oral
Etoposide
Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
etoposide
oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
erlotinib
oral
etoposide
oral
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Performance Status (PS): Lansky ≥ 50% for patients ≤ 10 years of age or Karnofsky ≥ 50% for patients \>10 years of age
* Measurable disease, defined as 1 measurable lesion that can be accurately measured in 2 planes that has not received radiation therapy within 12 weeks
* Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
* ≥ 1 year to ≤ 21 years
* Serum creatinine for patients ≤ 5 years in age is ≤ 0.8 mg/dL or Creatinine Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m\^2
* Serum creatinine for patients \> 5 and ≤ 10 years in age is ≤ 1.0 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m\^2
* Serum creatinine for patients \> 10 and ≤ 15 years in age is ≤ 1.2 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m\^2
* Serum creatinine for patients \> 15 years in age is ≤ 1.5 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m\^2
* Total bilirubin is ≤ 1.5 x upper limit of normal for age
* Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
* Absolute neutrophil count \> 1000/µL
* Platelet count \> 100,000/µL
* Hemoglobin \> 8 gm/dL
* Neurologically stable for at least 7 days prior to randomization
* If receiving corticosteroids, patients must be on a stable or decreasing dose for at least 7 days before randomization
* Patients of reproductive potential must agree to proactive effective contraceptive measures for the duration of the study and for at least 90 days after completion of study drug
Exclusion Criteria
* Previously received oral etoposide
* Received craniospinal radiotherapy within 24 weeks prior to randomization
* Received field radiotherapy to the target lesion within 12 weeks prior to randomization
* Received symptomatic metastatic disease within 14 days prior to randomization
* Received myelosuppressive chemotherapy within 21 days before randomization
* Received growth factors within 7 days prior to randomization
* Participating in another investigational drug trial
* Received a biologic agent within 7 days prior to randomization
* Received a monoclonal antibody within 28 days prior to randomization
* Taking cytochrome P450 (CYP)3A4 or CYP1A2 inhibitors/inducers within 14 days prior to randomization
* Taking proton pump inhibitors within 14 days prior to randomization
* Smoking during treatment
* Pregnant or breast-feeding females
1 Year
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
OSI Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham Dept. of Pediatric-Hematology/Oncology
Birmingham, Alabama, United States
Center for Cancer and Blood Disorders-Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital of Orange County (CHOC)
Orange, California, United States
Stanford University and Lucile Packard Children's Hospital
Palo Alto, California, United States
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 Aflac Cancer Center & Blood Disorders
Atlanta, Georgia, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Dana-Farber Cancer Institute Department of Pediatric Neuro-oncology
Boston, Massachusetts, United States
Amplatz Children's Hospital University of Minnesota Medical Center- Pediatric Hematology Oncology
Minneapolis, Minnesota, United States
Steven D Hassenfeld Children's Center - New York University
New York, New York, United States
Columbia University Children's Hospital of New York Presbyterian Child & Adolescent Oncology Center
New York, New York, United States
Oregon Health & Sciences University Doembecher Children's Hospital
Portland, Oregon, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Children's Medical Center, Dallas Center for Cancer and Blood Disorders
Dallas, Texas, United States
University of Wisconsin Pediatric Hematology/Oncology Department
Madison, Wisconsin, United States
Strollery Children's Hospital Division of Hematology/Oncology
Edmonton, Alberta, Canada
Children's and Women's Health Center of BC Division of Hematology/ Oncology/ BMT
Vancouver, British Columbia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Birmingham Children's Hospital
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 Department of Oncology
Liverpool, , United Kingdom
Royal Manchester Children's Hospital Ward 84
Manchester, , United Kingdom
University of Nottingham Children's Brain Tumour Research Centre
Nottingham, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Link to results on Astellas Clinical Study Results website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-016836-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OSI-774-205
Identifier Type: -
Identifier Source: org_study_id