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

Phase 2TerminatedNCT01247922

OSI Pharmaceuticals4 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ependymoma

Interventions

ErlotinibDRUG

continuous oral Erlotinib 85 mg/m\^2 per day

Eligibility

Sex: ALLMin age: 1 YearMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (21)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)

Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events.

Time frame: 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

Best Overall Response

Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing.

Time frame: End of treatment (The mean treatment duration was 170.5 days.)

Median Treatment Duration

Time frame: From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)

Data from ClinicalTrials.gov

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