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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)


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer, Brain Cancer

Thank you

Trial Information

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 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.


Inclusion Criteria:



1. Histological confirmation of non-small cell lung cancer

2. 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

3. A diagnostic contrast-enhanced MRI or CT scan must be performed, demonstrating brain
metastases

4. Age 18-70

5. Patients must have KPS >/= 70

6. Patients cannot be treated on any other treatment related protocols within 30 days
prior to study entry or during participation in the study

7. No uncontrolled or symptomatic major medical illnesses or psychiatric impairments,
such as Alzheimer's or schizophrenia

8. 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)

9. 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.

10. Continued from #10: All women of child-bearing potential must have a negative serum
pregnancy test and practice birth control while on study.

11. Patients must provide verbal and written informed consent to participate in the
study.

Exclusion Criteria:

1. Prior cranial radiation therapy, other than stereotactic radiosurgery, Stereotactic
Radiotherapy or GliaSite.

2. 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

3. Women who are pregnant or lactating, due to possible adverse effects on the
developing fetus or infant due to study drug

4. Patients with active connective tissue disorders, such as lupus or scleroderma

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median Survival

Outcome Time Frame:

End-of-study visit 1 month after radiation therapy completed, and follow-up visits every 3 months.

Safety Issue:

Yes

Principal Investigator

James Welsh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2008-0170

NCT ID:

NCT00871923

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Brain Cancer
  • Non-small cell lung cancer
  • NSCLC
  • Brain Metastases
  • Brain Cancer
  • Lung Cancer
  • Tarceva
  • Erlotinib Hydrochloride
  • OSI-774
  • Radiation Therapy
  • Whole Brain Radiation Therapy
  • WBRT
  • Brain Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030