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CompletedNCT00238251Updated Jun 5, 2012

Radiation Therapy Combined With Either Gefitinib or Temozolomide in Pats With NSCLC and Brain Metastases

A Phase 2 interventional study of gefitinib and temozolomide in Lung Cancer and Metastatic Cancer, sponsored by Swiss Cancer Institute. Completed at 3 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-05.

Sponsored by Swiss Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with either gefitinib or temozolomide may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving radiation therapy together with either gefitinib or temozolomide works in treating patients with non-small cell lung cancer and brain metastases.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the efficacy of whole-brain radiotherapy combined with either gefitinib or temozolomide, in terms of overall survival, in patients with non-small cell lung cancer and brain metastases.

Secondary

  • Compare the tolerability and toxicity of these regimens in these patients.
  • Compare the time to neurological disease progression, time to extracranial disease progression, and time to overall disease progression, in patients treated with these regimens.
  • Compare adverse events in patients treated with these regimens.
  • Compare cognitive function and quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are stratified according to extracranial disease (yes vs no), number of brain metastases (1-3 vs ≥ 4), prior chemotherapy (yes vs no), WHO performance status (0-1 vs 2), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo whole-brain radiotherapy (WBRT) once daily on days 1-5 and 8-12 and receive oral gefitinib once daily on days 1-28. Gefitinib treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo WBRT as in arm I and receive oral temozolomide once daily on days 1-21. Temozolomide treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and on day 1 of courses 2, 3, and 5.

After completion of study therapy, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30-86 patients (15-43 per treatment arm) will be accrued for this study within 3 years.

02

Conditions studied

  • Lung Cancer
  • Metastatic Cancer

Keywords

  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • tumors metastatic to brain
03

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 59 is close to the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Swiss Cancer Institute is the lead sponsor of 27 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer AND newly diagnosed brain metastases meeting 1 of the following criteria:

    • Multiple brain metastases
    • Single brain metastasis not amenable to potentially curative treatment
  • No advanced extracranial disease severely compromising vital functions and performance

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin > 10 g/dL
  • Absolute neutrophil count > 1,500/mm\^3
  • Platelet count > 100,000/mm\^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN in the presence of documented bone metastases)
  • No unstable or uncompensated hepatic disease that would preclude study participation

Renal

  • Creatinine clearance ≥ 40 mL/min
  • No unstable or uncompensated renal disease that would preclude study participation

Cardiovascular

  • No myocardial infarction within the past 3 months
  • No unstable or uncompensated cardiac disease that would preclude study participation

Pulmonary

  • No clinically active interstitial lung disease

    • Patients with chronic stable radiographic changes who are asymptomatic eligible
  • No other unstable or uncompensated respiratory disease that would preclude study participation

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No nausea, vomiting, inability to swallow whole tablets/capsules, or malabsorption syndrome that would preclude oral medication ingestion or absorption
  • No psychiatric disorder that would preclude giving informed consent or study compliance
  • No active infection
  • No uncontrolled diabetes mellitus
  • No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior temozolomide

Endocrine therapy

  • Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥ 4 days before study entry

Radiotherapy

  • No prior brain irradiation

Surgery

  • Not specified

Other

  • No prior gefitinib or erlotinib
  • More than 30 days since prior investigational clinical trial participation
  • No other concurrent experimental drugs
  • No other concurrent anticancer therapy

  • No concurrent treatment with any of the following:

    • Phenytoin
    • Carbamazepine
    • Rifampin
    • Barbiturates
    • Hypericum perforatum (St. John's wort)
    • Other enzyme-inducing anti-epileptic drugs or tuberculostatic treatments
    • Any drug that contraindicates administration with study drugs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Active comparator
    Arm I

    Patients undergo whole-brain radiotherapy (WBRT) once daily on days 1-5 and 8-12 and receive oral gefitinib once daily on days 1-28. Gefitinib treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity

    Drug: gefitinib · Radiation: radiation therapy

  • Active comparator
    Arm II

    Patients undergo WBRT as in arm I and receive oral temozolomide once daily on days 1-21. Temozolomide treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity

    Drug: temozolomide · Radiation: radiation therapy

Interventions

  • Druggefitinib

    Once daily during days 1-28

  • Drugtemozolomide

    Once daily on days 1-21

  • Radiationradiation therapy

    Whole brain radiotherapy

06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: life-long

Secondary outcomes

  1. Time to progression

    Time frame: 28 days

  2. Time to neurological progression

    Time frame: 28 days

  3. Time to extracranial disease progression

    Time frame: 28 days

  4. Adverse events as measured at completion of study treatment

    Time frame: 28 days

07

Study locations

3 sites
  • Oncology Institute of Southern Switzerland
    Bellinzona, CH-6500, Switzerland
  • Kantonsspital Graubuenden
    Chur, CH-7000, Switzerland
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, CH-1011, Switzerland
08

References and documents

Publications

  • Pesce GA, Klingbiel D, Ribi K, Zouhair A, von Moos R, Schlaeppi M, Caspar CB, Fischer N, Anchisi S, Peters S, Cathomas R, Bernhard J, Kotrubczik NM, D'Addario G, Pilop C, Weber DC, Bodis S, Pless M, Mayer M, Stupp R. Outcome, quality of life and cognitive function of patients with brain metastases from non-small cell lung cancer treated with whole brain radiotherapy combined with gefitinib or temozolomide. A randomised phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 70/03). Eur J Cancer. 2012 Feb;48(3):377-84. doi: 10.1016/j.ejca.2011.10.016. Epub 2011 Nov 15. PubMed 22093943 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00238251
Lead sponsor
Swiss Cancer Institute
Responsible party
Sponsor
First posted
Oct 13, 2005
Start date
May 2005
Primary completion
Apr 2009
Completion
Nov 2010
Last update
Jun 5, 2012

Study contacts

Gianfranco Pesce, MD
study chair · Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Roger Stupp, MD
principal investigator · Centre Hospitalier Universitaire Vaudois

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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