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Non-small Cell Lung CancerPhase 2NCT00871923

Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer

A Phase 2 study testing Tarceva (Erlotinib hydrochloride) and Radiation Therapy in people with Non-small Cell Lung Cancer and Brain Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.

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

The goal of this clinical research study is to learn whether Tarceva (erlotinib hydrochloride), when given in addition to whole brain radiation therapy, is better to treat brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-small Cell Lung Cancer, Brain Cancer
What is being tested?
Tarceva (Erlotinib hydrochloride) and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesUnited States
Study dates
26 Mar 2009to 4 Dec 2019
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmation of non-small cell lung cancer
  • Patients who have been treated in the past with stereotactic radiosurgery, stereotactic radiotherapy, GliaSite or surgical resection will be allowed to enroll in this study
  • A diagnostic contrast-enhanced MRI or CT scan must be performed, demonstrating brain metastases
  • Age 18-70
  • Patients must have KPS >/= 70
  • Patients cannot be treated on any other treatment related protocols within 30 days prior to study entry or during participation in the study
Show all 11Show fewer
  • No uncontrolled or symptomatic major medical illnesses or psychiatric impairments, such as Alzheimer's or schizophrenia
  • Screening Clinical Laboratory Values: ANC >1500/ul, Platelets >80,000/ul, baseline AST and/or ALT within normal limits (within 30 days of starting protocol treatment)
  • All women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) and male participants must practice effective contraception (abstinence, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study.
  • Continued from #10: All women of child-bearing potential must have a negative serum pregnancy test and practice birth control while on study.
  • Patients must provide verbal and written informed consent to participate in the study.

Who cannot join

  • Prior cranial radiation therapy, other than stereotactic radiosurgery, Stereotactic Radiotherapy or GliaSite.
  • Patients with known Acquired Immune Deficiency (AIDS), as regimens with tyrosine kinase inhibitors may pose a safety risk related to excess toxicity or interference with anti-viral effectiveness
  • Women who are pregnant or lactating, due to possible adverse effects on the developing fetus or infant due to study drug
  • Patients with active connective tissue disorders, such as lupus or scleroderma

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Arizona

    Tucson, Arizona, 85721

Other trials in United States

About this study

Official title: A Phase II Study to Determine the Efficacy of Tarceva® (Erlotinib Hydrochloride) With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer (NSCLC)

The goal of this clinical research study is to learn whether Tarceva (erlotinib hydrochloride), when given in addition to whole brain radiation therapy, is better to treat brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).

Read the detailed description

The Study Drugs:

Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take the study drug on Days 1-6 before receiving radiation therapy. You will take 1 pill each day at least 1 hour before or 2 hours after eating. You will take the study drug while you are receiving radiation therapy. You will continue to take the study drug daily after the radiation therapy is complete for as long as the study doctor thinks it is necessary.

You will record at what time each day you take the study drug on a calendar that the will be provided to you. You will bring this calendar with you to each of your study visits.

During the time you are taking the study drug, you must tell the research staff if you have any changes in the drugs that you are taking. If you feel you are having any problems from the study drug before starting radiation therapy, you must tell the study doctor right away.

Radiation Therapy:

After Day 6 of taking the study drug, you will begin radiation therapy. You will receive radiation therapy 1 time each day (Monday through Fridays only) for a total of 14 days.

Once a week during radiation therapy:

  • You will have a physical exam.
  • You will complete a quality of life questionnaire (at the last week visit)
  • You will complete a mini-mental status exam (at the last week visit)
  • You will be asked about any changes in the drugs you may be taking
  • You will be asked about how you are feeling and any side effects that you may be having
  • You will have blood drawn (about 1/2 teaspoon) for lab tests if necessary.

One month after Radiation therapy follow up:

  • You will have a follow up visit 1 month after radiation therapy is complete. The study doctor will decide if you will continue to take the study drug at the follow-up visit. The following tests and procedures will be performed:
  • You will have a physical exam.
  • You will have an MRI or CT of the brain.
  • Your vital signs will be recorded.
  • You will complete a quality of life questionnaire.
  • You will complete a mini-mental status exam.
  • You will be asked about any changes in the drugs you may be taking.
  • You will be asked about how you are feeling and any side effects that you may be having.
  • You will have blood drawn (about 1/2 teaspoon) for lab tests if necessary.

Follow-up Visits (While on Tarceva):

If, at the end-of-study visit, the doctor decides that you will continue to take the study drug, you will have a follow-up visit with the research nurse 1 time each month. At these visits, the following tests and procedures will be performed:

(If unable to return to MDACC, this visit will be conducted over the telephone and arrangements will be made to mail study Tarceva medication.)

  • Your medical history will be reviewed.
  • You will receive a 30-day supply of the study drug.
  • You will bring in your study drug calendar for the nurse to review.
  • You will be asked about how you are feeling and any side effects that you may be having.
  • You will also be asked about any changes in the drugs you may be taking.
  • Blood (about 1/2 teaspoon) may be drawn for routine tests.

The following tests and procedures will be performed every 3 months:

  • You will have a physical exam.
  • You will have an MRI or CT of the brain
  • Your vital signs will be recorded.

Follow up visit (Discontinuation of Study Drug):

You will have a follow up visit with the research nurse 1 month after your last dose of the study drug, and the following will be performed:

(If unable to return to MDACC, this visit will be conducted over the telephone and arrangements will be made to have the study Tarceva medication and medication diary returned by mail.)

  • Your medical history will be reviewed.
  • You will be asked about how you are feeling and any side effects that you may be having.
  • You will return your study drug calendar and any remaining Tarceva tablets to the research nurse.
  • You will also be asked about any changes in the drug you may be taking
  • Your vital signs will be recorded.

The following tests and procedures will be performed every 3 months (off Tarceva) for the first 2 years then every 6 months thereafter:

  • You will have a physical exam.
  • Your medical history will be reviewed.
  • You will have an MRI or CT of the brain
  • If you are unable to return for your follow up visits due to physical conditions, you will be contacted by phone.

Duration of Study Treatment:

You will remain on study for as long as the study doctor thinks you are benefitting from the study drug. You will be taken off study treatment early if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to continue to receive treatment on this study.

This is an investigational study. Erlotinib hydrochloride is FDA approved and commercially available. It has not been FDA approved to treat NSCLC that has spread to the brain.

Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.

Being tested
Tarceva (Erlotinib hydrochloride), Radiation Therapy
Keywords
Non-small cell lung cancer, NSCLC, Brain Metastases, Brain Cancer, Lung Cancer, Tarceva, Erlotinib Hydrochloride, OSI-774, Radiation Therapy, Whole Brain Radiation Therapy, WBRT
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Lung Neoplasms

What participants receive

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

  • Tarceva (Erlotinib hydrochloride)Drug

    Also called OSI-774

    150 mg by mouth every day beginning Day 1.

  • Radiation TherapyRadiation

    Also called RT, XRT, Radiotherapy

    Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.

Study groups in NCT00871923
Study groupRoleWhat they receive
Tarceva + RTExperimentalTarceva (Erlotinib hydrochloride) + Radiation Therapy. Tarceva 150 mg by mouth every day beginning Day 1. Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.
Receives: Drug: Tarceva (Erlotinib hydrochloride); Radiation: Radiation Therapy

What is being measured

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

  1. Median Survival

    Median Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle.

    Measured: End-of-study visit 1 month after radiation therapy completed, and follow-up visits every 3 months, assessed up to 2 years.

Secondary outcomes (1)

  1. Number of Participants With Overall Survival

    Overall Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle. The participants overall survival measured at 6 month, 1-year and 2 years.

    Measured: From date of registration until the date of first documented death or lost to follow up, whichever came first, assessed up to 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 posted30 Mar 2009 (estimated)
  2. Study start26 Mar 2009
  3. Primary completion4 Dec 2019
  4. Study completion4 Dec 2019

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00871923
Sponsor's protocol ID
2008-0170
Other IDs
NCI-2012-01649
Status last verified
Sep 2021
First submitted
27 Mar 2009
Last updated
16 Sep 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Welsh JW, Komaki R, Amini A, Munsell MF, Unger W, Allen PK, Chang JY, Wefel JS, McGovern SL, Garland LL, Chen SS, Holt J, Liao Z, Brown P, Sulman E, Heymach JV, Kim ES, Stea B. Phase II trial of erlotinib plus concurrent whole-brain radiation therapy for patients with brain metastases from non-small-cell lung cancer. J Clin Oncol. 2013 Mar 1;31(7):895-902. doi: 10.1200/JCO.2011.40.1174. Epub 2013 Jan 22.

    PubMed 23341526

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tarceva (Erlotinib hydrochloride) and Radiation Therapy in people with Non-small Cell Lung Cancer and Brain Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.

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 11 inclusion and 4 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 16 Sep 2021). 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?

Median Survival (time frame: End-of-study visit 1 month after radiation therapy completed, and follow-up visits every 3 months, assessed up to 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 NCT00871923, 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 16 Sep 2021.

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