WBRT & Erlotinib in Advanced NSCLC and Brain Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-11-30

Brief Summary

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RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib may also make tumor cells more sensitive to radiation therapy. It is not yet known whether giving whole-brain radiation therapy together with erlotinib is more effective than whole-brain radiation therapy alone in treating patients with non-small cell lung cancer and brain metastases.

PURPOSE: This randomized phase II trial is studying whole-brain radiation therapy and erlotinib to see how well they work compared with whole-brain radiation therapy alone in treating patients with advanced non-small cell lung cancer and brain metastases.

Detailed Description

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OBJECTIVES:

Primary

* Compare the effect of whole-brain radiotherapy (WBRT) and erlotinib hydrochloride vs WBRT alone on neurological progression-free survival at 2 months in patients with advanced non-small cell lung cancer and multiple brain metastases.

Secondary

* Compare the toxicity of these regimens.
* Compare the response rate in these patients.
* Compare quality of life of these patients.
* Compare change in performance status in these patients.
* Compare steroid dosing in these patients.
* Compare sites of progression (cranial or extracranial) in these patients.

OUTLINE: This is a multicenter study. Patients are stratified by presence of extracranial metastases (yes vs no), RTOG recursive partitioning analysis (RPA) score (I vs II) and treatment center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo whole-brain radiotherapy (WBRT) once daily for 5 days. Patients also receive oral erlotinib hydrochloride once daily for up to 24 months.
* Arm II: Patients undergo WBRT as in arm I. Patients also receive oral placebo once daily for up to 24 months.

Quality of life is assessed at baseline, monthly for 12 months, and then at 18 and 24 months.

After completion of study therapy, patients are followed every 1-2 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Conditions

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Lung Cancer Metastatic Cancer

Keywords

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tumors metastatic to brain stage IV non-small cell lung cancer recurrent non-small cell lung cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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erlotinib hydrochloride

WBRT plus Tarceva (OSI-774, erlotinib) PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months

Group Type EXPERIMENTAL

erlotinib hydrochloride

Intervention Type DRUG

PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months

placebo

WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride arm

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride

Interventions

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erlotinib hydrochloride

PO 100 mg daily during WBRT, increasing to 150mg daily after WBRT for up to 24 months

Intervention Type DRUG

placebo

WBRT plus matched placebo for the same schedule and duration as erlotinib hydrochloride

Intervention Type DRUG

Other Intervention Names

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tarceva OSI-774

Eligibility Criteria

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Inclusion Criteria

* Clinician certain that whole-brain radiotherapy (WBRT) will be beneficial
* No evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy
* No more than 3 sites (organ systems) of extracranial metastases

* No liver metastases

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* RTOG recursive partitioning analysis (RPA) class I or II
* Serum bilirubin \< 2 times upper limit of normal (ULN)
* AST and ALT \< 2 times ULN (\< 5 times ULN if liver metastases are present)
* Creatinine \< 5 times ULN
* Able to take oral medication
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Caretaker able and willing to participate in the study
* Patient and caretaker have access to a telephone and willing to respond to telephone interview
* No other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
* No evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications including, but not limited to, any of the following:

* Severe uncontrolled infection
* Unstable angina
* Myocardial infarction within the past month
* Uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
* Acute renal failure

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 28 days since prior chemotherapy (for relapsed patients originally treated with chemotherapy)
* No prior cranial radiotherapy
* No prior anti-cancer EGFR therapy (e.g., erlotinib, gefitinib, or cetuximab)
* No prior treatment for brain metastases (e.g., radiosurgery, radiotherapy, or chemotherapy)

* Prior radiotherapy to the primary tumor and/or systemic treatment to metastatic sites of disease allowed
* No concurrent cyclooxygenase-2 (COX-2) inhibitors

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siow M. Lee, MD, PhD, FRCP

Role: STUDY_CHAIR

University College London Hospitals

Locations

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Charing Cross Hospital

London, England, United Kingdom

Site Status

University College of London Hospitals

London, England, United Kingdom

Site Status

Christie Hospital

Manchester, England, United Kingdom

Site Status

Salisbury District Hospital

Salisbury, England, United Kingdom

Site Status

Southampton General Hospital

Southampton, England, United Kingdom

Site Status

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, United Kingdom

Site Status

South West Wales Cancer Institute

Swansea, Wales, United Kingdom

Site Status

Countries

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United Kingdom