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Lung CancerPhase 2NCT00385398

QOL-Stereotactic RadioSurgery, Temozolomide + Erlotinib-Rx of 1-3 Brain Metastases in NSCLC

A Phase 2 study testing erlotinib hydrochloride, temozolomide and stereotactic radiosurgery in people with Lung Cancer and Metastatic Cancer, run by University of Medicine and Dentistry of New Jersey.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain metastases. A study that evaluates brain function may help doctors plan the best treatment. 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?
erlotinib hydrochloride, temozolomide and stereotactic radiosurgery
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2008to Dec 2008
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 confirmed non-small cell lung cancer meeting the following criteria:
  • One to 3 brain metastases, meeting the following criteria:
  • No larger than 3 cm
  • Greater than 5 mm from the optic apparatus
  • Not involving the brainstem, pons, medulla, or midbrain
  • Stable systemic disease for the past 3 months
  • Less than 3 months since completion of primary treatment
  • Measurable CNS disease as defined by RECIST criteria
  • No leptomeningeal disease documented by MRI or cerebrospinal fluid cytologic evaluation

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 12 weeks
  • Karnofsky performance status 60-100%
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 3.0 times ULN
  • Serum creatinine ≤ 1.5 mg/dL
  • Creatinine clearance > 50 mL/min
  • No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No concurrent major medical illness or psychiatric impairment that, in the investigator's opinion, would preclude study participation
  • No concurrent active infections
  • No known HIV positivity
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception during and for 3 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior complete resection of all brain metastases
  • No prior brain radiation therapy
  • No prior temozolomide or erlotinib hydrochloride
  • No concurrent enzyme-inducing anti-epileptic drugs
  • No concurrent recombinant interleukin-11
  • No other concurrent anticancer investigational or commercial agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiation therapy, or cancer surgery
  • No concurrent enrollment on another clinical trial
  • Surgery for symptomatic brain lesions prior to radiosurgery allowed

About this study

Official title: Phase II Quality of Life Study of Stereotactic RadioSurgery, Temozolomide and Erlotinib Chemotherapy for the Treatment of 1-3 Brain Metastases in Non-small Cell Lung Cancer

RATIONALE: Treatment with radiosurgery, temozolomide, and erlotinib may affect brain function (the ability to think, learn, remember, and judge) in patients with non-small cell lung cancer and brain metastases. A study that evaluates brain function may help doctors plan the best treatment.

PURPOSE: This phase II trial is studying the effect of radiosurgery, temozolomide, and erlotinib on brain function in patients with non-small cell lung cancer and brain metastases.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the effect of stereotactic radiosurgery, temozolomide, and erlotinib hydrochloride on cognitive function in patients with non-small cell lung cancer and brain metastases.

Secondary

  • Determine the feasibility and safety of this regimen, in terms of tumor response, time to tumor progression in brain, survival, physical functioning, and quality of life, in these patients.
  • Determine the frequency of O6-methylguanine-DNA methyltransferase promoter methylation in these patients.

OUTLINE: This is a multicenter study.

Patients undergo stereotactic radiosurgery on day -7. Patients receive oral temozolomide once daily on days 1-5 and oral erlotinib hydrochloride once daily on days 1-23. Treatment with temozolomide and erlotinib hydrochloride repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo cognitive function evaluation as measured by Mini-Mental Status Exam administration and scoring; quality of life assessment as measured by Functional Assessment of Cancer Therapy subscale; and physical functioning assessment as measured by Katz index of activities of daily living and Karnofsky performance status at baseline and then every 8 weeks during study treatment.

Tumor tissue is examined by O6-methylguanine-DNA methyltransferase (MGMT gene) promotor methylation.

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

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Being tested
erlotinib hydrochloride, temozolomide, stereotactic radiosurgery
Keywords
tumors metastatic to brain, stage IV non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Neoplasm Metastasis, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • erlotinib hydrochlorideDrug

    Erlotinib will be administered orally on at a dose of 200 mg/day on Days 1-23 of each 28 day cycle.

  • temozolomideDrug

    Temozolomide will be administered orally at a dose of 150 mg/m2 on Days 1-5 for Cycle 1 then increased to 200 mg/m2 for Cycle 2 forward.

  • stereotactic radiosurgeryRadiation

    Stereotactic radiosurgery will be performed prior to chemotherapy.

What is being measured

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

  1. Cognitive function

    Measured: 2 years

Secondary outcomes (6)

  1. Tumor response

    Measured: 2 years

  2. Time to tumor progression in brain

    Measured: 2 years

  3. Survival

    Measured: 2 years

  4. Quality of life as measured by FACT subscale

    Measured: 2 years

  5. Physical functioning as measured by Karnofsky performance status and Katz index of activities of daily living

    Measured: 2 years

  6. Frequency of O6-methylguanine-DNA methyltransferase promoter methylation

    Measured: 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 posted9 Oct 2006 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2008
  4. Study completionDec 2008

Why it stopped: lack of funding and drug supply

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00385398
Sponsor's protocol ID
030601
Other IDs
P30CA072720, 0220060108, CINJ-NJ1506, CDR0000539474
Status last verified
Aug 2013
First submitted
5 Oct 2006
Last updated
2 Sep 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride, temozolomide and stereotactic radiosurgery in people with Lung Cancer and Metastatic Cancer, run by University of Medicine and Dentistry of New Jersey.

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: withdrawn, as of the sponsor's last update on 2 Sep 2013. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Cognitive function (time frame: 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 NCT00385398.

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 2 Sep 2013.

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