|- candidate number||13291|
|- NTR Number||NTR3603|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-sep-2012|
|- Secondary IDs||NL41220.029.12 CCMO|
|- Public Title||Hoog-gedoseerde, pulsatiele erlotinib na progressie op standaard dosering erlotinib bij EGFR-gemuteerde NSCLC patienten.|
|- Scientific Title||High-dose, pulsatile erlotinib after progression on standard dose erlotinib in EGFR-mutated NSCLC patients.|
|- ACRONYM||PE study|
|- hypothesis||High-dose, weekly erlotinib is a therapeutic option for EGFR-mutated NSCLC patients with leptomeningeal metastases while on EGFR-TKI therapy. In one of the patients treated with this dose schedule not only the leptomeningeal metastases showed evident response, but unexpectedly, the thoracic progression of disease showed evident response as well. This provides the rationale for this prospective trial; does erlotinib in a high-dose, weekly schedule show activity in EGFR-mutated NSCLC patients after being diagnosed with progression of disease while on standard dose EGFR-TKI therapy.|
|- Healt Condition(s) or Problem(s) studied||Erlotinib, Non small cell lung cancer (NSCLC), EGFR mutation, Pulsatile|
|- Inclusion criteria||1. Histologically confirmed stage IV non-squamous NSCLC patients;|
2. Patients with an activating EGFR mutation who progressed on erlotinib or gefitinib monotherapy in daily dose of 150 mg or 250 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible);
3. Tumor biopsy available for EGFR mutation analysis at progression;
4. At least one measurable disease site, according to RECIST 1.1 criteria;
5. WHO performance status 0-2;
6. Willing and able to comply with the study prescriptions;
7. 18 years or older;
8. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study;
9. Ability to give and having given written informed consent before patient registration.
|- Exclusion criteria||1. No uncontrolled infectious disease;|
2. No other active malignancy;
3. No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks;
4. No treatment with investigational drugs;
5. No known prior hypersensitivity to erlotinib.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||6-sep-2012|
|- planned closingdate||6-mrt-2015|
|- Target number of participants||50|
|- Interventions||Erlotinib 1500 mg once a week. This will be given until progression of disease.|
|- Primary outcome||To assess the objective response rate (ORR) at 8 weeks according to the response evaluation criteria in solid tumors (RECIST v1.1).|
|- Secondary outcome||1. To assess progression-free survival (PFS) at six months;|
2. To assess toxicity of high-dose erlotinib according to CTC AE 4.0.
|- Timepoints||Every 8 weeks CT thorax.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. MD. PhD. E.F. Smit |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. MD. PhD. E.F. Smit |
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary||Rationale: |
High-dose, weekly erlotinib is a therapeutic option for EGFR-mutated NSCLC patients with leptomeningeal metastases while on EGFR-TKI therapy. In one of the patients treated with this dose schedule not only the leptomeningeal metastases showed evident response, but unexpectedly, the thoracic progression of disease showed evident response as well. This provides the rationale for this prospective trial; does erlotinib in a high-dose, weekly schedule show activity in EGFR-mutated NSCLC patients after being diagnosed with progression of disease while on standard dose EGFR-TKI therapy.
To evaluate the effect of erlotinib 1500 mg weekly in EGFR-mutated NSCLC patients after being diagnosed with disease progression while on standard, daily dose of 150 mg erlotinib.
Single-arm, open-label, phase II, intervention study.
EGFR-mutated NSCLC patients, >18 years old.
Erlotinib 1500 mg once weekly.
Main study parameters/endpoints:
Primary objective: Disease control rate at 8 weeks.
Secondary objective: progression free survival at 6 months, overall survival at 1 year and toxicity according to CTC-AE 4.0.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Burden and risks associated with participation include outpatient visits every 4 weeks and a CT-scan every 8 weeks. Risks comprise the side effects of erlotinib, which are generally well manageable with best supportive care. Every outpatient visit physical examination will be performed, blood samples will be taken and every 8 weeks a CT-scan will be done. Risks are considered to be small, since there is much experience with erlotinib in this dose and schedule and side effects have been manageable.
|- Main changes (audit trail)|
|- RECORD||6-sep-2012 - 26-sep-2012|