Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma (PETEY)

This study has been terminated.

(In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, it has been stopped.)

Sponsor:

Information provided by (Responsible Party):

Astellas Pharma Inc ( OSI Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01032070

First received: December 10, 2009

Last updated: April 4, 2013

Last verified: April 2013

History of Changes

Purpose

This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.

Condition	Intervention	Phase
Recurrent or Refractory Pediatric Ependymoma	Drug: erlotinib Drug: etoposide	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma

Resource links provided by NLM:

Drug Information available for: Etoposide Etoposide phosphate Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Objective Response Rate [ Time Frame: At end of study (up to 12 months) ] [ Designated as safety issue: No ]
The proportion of patients with a best overall response of complete response or partial response

Secondary Outcome Measures:

Duration of response [ Time Frame: At end of study (up to 12 months) ] [ Designated as safety issue: No ]
Time from the date of the first documented response (complete response/partial response) to the first documented progression or death due to underlying cancer
Minor response rate [ Time Frame: At end of study (up to 12 months) ] [ Designated as safety issue: No ]
Proportion of patients with a best overall response of minor response (MR)
Disease control rate [ Time Frame: At end of study (up to 12 months) ] [ Designated as safety issue: No ]
Proportion of patients with a best overall response of complete response (CR) or partial response (PR) or MR or stable disease (SD)
Progression free survival (PFS) [ Time Frame: At end of study (up to 12 months) ] [ Designated as safety issue: No ]
Time from randomization to disease progression based on CNS-specific evaluation criteria as assessed by the investigator or death due to any cause whichever occurs first
Rate of prolonged stable disease [ Time Frame: At end of study (up to 12 months) ] [ Designated as safety issue: No ]
Proportion of patients who achieve a best overall response of CR or PR or MR or SD and have not progressed within 16 weeks from randomization
Duration of stable disease [ Time Frame: At end of study (up to 12 months) ] [ Designated as safety issue: No ]
Time from the date of randomization to the first documented progression or death due to underlying cancer
Overall survival (OS) [ Time Frame: At end of study (up to 12 months) ] [ Designated as safety issue: No ]
Time from the date of randomization until the documented date of death
Safety assessed through evaluation of physical exams, vital signs, clinical laboratory tests and adverse events [ Time Frame: At end of study (up to 12 months) ] [ Designated as safety issue: No ]
Composite of Pharmacokinetics: Steady State AUC0-tau, Cmax, Tmax and Clearance (CL/F) [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
erlotinib patients only

Enrollment:	25
Study Start Date:	December 2009
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: erlotinib	Drug: erlotinib oral Other Names: Tarceva OSI-774
Active Comparator: etoposide	Drug: etoposide oral Other Name: VP-16

Detailed Description:

This is a phase 2 study involving a 1:1 randomization of 40 patients with recurrent or refractory pediatric ependymoma who will receive either erlotinib or oral etoposide.

Eligibility

Ages Eligible for Study:	1 Year to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recurrent of refractory ependymoma or subependymoma
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/m2
Serum creatinine for patients >5 and <=10 years in age is <=1.0 mg/dL or Creatinine Clearance/GFR >=70 mL/min/m2
Serum creatinine for patients >10 and <=15 years in age is <=1.2 mg/dL or Creatinine Clearance/GFR >=70 mL/min/m2
Serum creatinine for patients >15 years in age is <=1.5 mg/dL or Creatinine Clearance/GFR >=70 mL/min/m2
Total bilirubin is <=1.5 x upper limit of normal for age
Serum glutamic pyruvic transminase (SGPT) 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 epidermal growth factor receptor (EGFR)-targeted therapy
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 CYP3A4 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032070

Show 28 Study Locations

Sponsors and Collaborators

OSI Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01032070 History of Changes
Other Study ID Numbers:	OSI-774-205, 2009-016836-11
Study First Received:	December 10, 2009
Last Updated:	April 4, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:

phase 2
erlotinib
pediatric
etoposide
ependymoma

Additional relevant MeSH terms:

Ependymoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Etoposide

Etoposide phosphate
Erlotinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013

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