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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871923
Recruitment Status : Active, not recruiting
First Posted : March 30, 2009
Last Update Posted : September 25, 2017
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Brain Cancer Drug: Tarceva (Erlotinib hydrochloride) Radiation: Radiation Therapy Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 2009
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tarceva + RT
Tarceva (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.
Drug: Tarceva (Erlotinib hydrochloride)
150 mg by mouth every day beginning Day 1.
Other Name: OSI-774
Radiation: Radiation Therapy
Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.
Other Names:
  • RT
  • XRT
  • Radiotherapy

Primary Outcome Measures :
  1. Median Survival [ Time Frame: End-of-study visit 1 month after radiation therapy completed, and follow-up visits every 3 months. ]

Secondary Outcome Measures :
  1. Quality of Life Improvement [ Time Frame: Baseline, last radiation therapy visit, and one month after radiation therapy ]
    Quality of life as assessed with the Spitzer Quality of Life Index and the Folstein Mini-Mental Status Exam.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00871923

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
OSI Pharmaceuticals
Principal Investigator: James Welsh, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00871923     History of Changes
Other Study ID Numbers: 2008-0170
NCI-2012-01649 ( Registry Identifier: NCI CTRP )
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Non-small cell lung cancer
Brain Metastases
Brain Cancer
Lung Cancer
Erlotinib Hydrochloride
Radiation Therapy
Whole Brain Radiation Therapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action