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Lung CancerPhase 2NCT00080938

Temozolomide and Radiation Therapy in Treating Patients With Brain Metastasis Secondary to Non-Small Cell Lung Cancer

A Phase 2 study testing Temozolomide and Radiation therapy in people with Lung Cancer and Metastatic Cancer, run by Eastern Cooperative Oncology Group.

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 damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells. 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?
Temozolomide and Radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
20 Dec 2005to Feb 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Histologically confirmed non-small cell lung cancer (NSCLC), including the following histologies:
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Large cell carcinoma
  • Bronchoalveolar carcinoma
  • All variants of NSCLC
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  • At least 1 bidimensionally measurable brain metastasis
  • Confirmed by MRI within the past two weeks, and computed tomography (CT) scan is not acceptable
  • Biopsy is not required
  • Not eligible for surgical resection or radiosurgery of brain metastasis
  • Systemic disease not in immediate need of chemotherapy
  • Age>=18 years
  • ECOG Performance status of 0-1
  • More than 12 weeks of life expectancy
  • Adequate hematologic, renal, and liver function as demonstrated by laboratory values performed within two weeks, inclusive, prior to administration of study drug or registration
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (5 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present)
  • Creatinine ≤ 1.6 mg/dL
  • Fertile patients must use effective contraception
  • Prior biologic therapy allowed
  • More than 4 weeks since prior chemotherapy
  • Prior radiotherapy for local control or palliative therapy for painful bony lesions allowed
  • Prior surgery for brain metastasis allowed
  • At least 4 weeks since prior radiotherapy to ≥ 15% of bone marrow (2 weeks for < 15% of bone marrow) and recovered
  • No prior radiotherapy to ≥ 50% of bone marrow
  • Concurrent radiotherapy to painful bony lesions allowed provided no more than 15% of bone marrow is irradiated

Who cannot join

  • HIV positive
  • AIDS-related illness
  • Poor medical risks due to active nonmalignant systemic disease
  • Frequent vomiting
  • There is medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
  • Pregnant or nursing
Show all 13Show fewer
  • Prior temozolomide
  • Prior radiotherapy to the brain, including stereotactic radiosurgery to a different lesion
  • Concurrent intensity modulated radiotherapy or 3-D cranial radiotherapy
  • Other concurrent investigational agents
  • Other concurrent treatment for brain metastasis
  • Other concurrent chemotherapy during study radiotherapy
  • Concurrent growth factors to induce elevations in blood counts for the purposes of administration of study drug at scheduled dosing interval or to allow treatment with study drug at a higher dose

About this study

Official title: A Phase II Study of Temozolomide and Radiation Therapy in Patients With Brain Metastasis From Non-small Cell Lung Cancer (NSCLC)

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the intracranial response rate in patients with brain metastasis secondary to non-small cell lung cancer treated with whole brain radiotherapy and temozolomide.

Secondary

  • Determine the time to radiological progression in patients treated with this regimen.
  • Determine the time to neurological progression (confirmed by magnetic resonance imaging (MRI)) in patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo whole brain radiotherapy once daily, 5 days a week, for 2 weeks (10 fractions). Patients also receive concurrent oral temozolomide once daily on days 1-14.

Beginning 3 weeks after the completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of neurologic (Central Nervous System, CNS) progression or unacceptable toxicity.

Patients were followed every 3 months for 2 years.

ACCRUAL: A total of 26 patients were accrued for this study.

Being tested
Temozolomide, Radiation therapy
Keywords
recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, squamous cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, bronchoalveolar cell lung cancer, adenosquamous cell lung cancer, tumors metastatic to brain
Medical subject headings
Lung Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar, Brain Neoplasms

What participants receive

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

  • TemozolomideDrug

    Also called Temodar

    Temozolomide (TMZ) to be given at a dose of 75 mg/m2/day for 14 days, starting on D1 of whole brain radiotherapy (WBRT). Three weeks after completion of WBRT, TMZ will be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28-days,for an additional two cycles.

  • Radiation therapyRadiation

    Also called Whole brain radiation therapy

    Standard whole brain radiation therapy 30 Gy in ten fractions.

Study groups in NCT00080938
Study groupRoleWhat they receive
Temozolomide and RadiationExperimentalTemozolomide:administered orally. Radiation: whole brain radiation therapy
Receives: Drug: Temozolomide; Radiation: Radiation therapy

What is being measured

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

  1. Number of Patients With Intracranial Response

    Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR

    Measured: assessed every cycle while on treatment, then every 3 months for 2 years

Secondary outcomes (3)

  1. 1-year Neurologic (Central Nervous System, CNS) Progression Free Rate

    1-year CNS progression free rate is the percentage of patients who had no CNS progression after being followed for 1 year . Progressive disease (CNS) was defined as a 25% or greater increase in the sum of the product(s) of the maximal cross-sections on MRI scan, reappearance of any lesion that has disappeared, development of any new lesion(s), stable disease with a deterioration of neurologic exam, or clear worsening of any evaluable disease.

    Measured: assessed every 3 months for 2 years

  2. Time to Non-CNS (Systemic) Progression

    Time to non-CNS progression was calculated from time of protocol entry to time of first systemic progressive disease or death. Patients alive and non-CNS progression-free at last follow-up were censored. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter (per RECIST criteria). Development of new lesions in non-CNS sites also constituted non-CNS progression. The 21 eligible and treated patients were included in the analysis.

    Measured: assessed every 3 months for 2 years

  3. Overall Survival Time

    Overall survival (months) was calculated from time of protocol entry to time of death from any cause. Patients alive at last follow-up were censored. The 21 eligible and treated patients were included in the analysis.

    Measured: assessed every 3 months for 2 years

Timeline

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

  1. First posted8 Apr 2004 (estimated)
  2. Study start20 Dec 2005
  3. Primary completionAug 2008
  4. Study completionFeb 2009

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00080938
Sponsor's protocol ID
CDR0000357567
Other IDs
U10CA021115, E1F03
Status last verified
Jun 2023
First submitted
7 Apr 2004
Last updated
29 Jun 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temozolomide and Radiation therapy in people with Lung Cancer and Metastatic Cancer, run by Eastern Cooperative Oncology Group.

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

Who may be eligible to take part?

The sponsor lists 30 inclusion and 13 exclusion criteria. 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 27 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients With Intracranial Response (time frame: assessed every cycle while on treatment, then every 3 months for 2 years). 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 NCT00080938.

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 29 Jun 2023.

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