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AzTrials

Lung CancerPhase 2NCT00238251

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

A Phase 2 study testing gefitinib, temozolomide and radiation therapy in people with Lung Cancer and Metastatic Cancer, run by Swiss Cancer Institute at 3 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Metastatic Cancer
What is being tested?
gefitinib, temozolomide and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
3 sitesSwitzerland
Study dates
May 2005to Nov 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

  • Oncology Institute of Southern Switzerland

    Bellinzona, CH-6500

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

About this study

Official title: Whole Brain Radiotherapy in Combination With Gefitinib (Iressa) or Temozolomide (Temodal) for Brain Metastases From Non-Small Lung Cancer (NSCLC) A Randomized Phase II Trial

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.

Being tested
gefitinib, temozolomide, radiation therapy
Keywords
stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, tumors metastatic to brain
Medical subject headings
Lung Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gefitinibDrug

    Once daily during days 1-28

  • temozolomideDrug

    Once daily on days 1-21

  • radiation therapyRadiation

    Whole brain radiotherapy

Study groups in NCT00238251
Study groupRoleWhat they receive
Arm IActive comparatorPatients 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
Receives: Drug: gefitinib; Radiation: radiation therapy
Arm IIActive comparatorPatients 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
Receives: Drug: temozolomide; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: life-long

Secondary outcomes (4)

  1. Time to progression

    Measured: 28 days

  2. Time to neurological progression

    Measured: 28 days

  3. Time to extracranial disease progression

    Measured: 28 days

  4. Adverse events as measured at completion of study treatment

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionApr 2009
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00238251
Sponsor's protocol ID
SAKK 70/03
Other IDs
EU-20526
Status last verified
Jun 2012
First submitted
12 Oct 2005
Last updated
5 Jun 2012
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gefitinib, temozolomide and radiation therapy in people with Lung Cancer and Metastatic Cancer, run by Swiss Cancer Institute at 3 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: life-long). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00238251, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.

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