NCT00871923

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 16, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

10.7 years

First QC Date

March 27, 2009

Results QC Date

November 19, 2020

Last Update Submit

September 14, 2021

Conditions

Non-small Cell Lung CancerBrain Cancer

Keywords

Non-small cell lung cancerNSCLCBrain MetastasesBrain CancerLung CancerTarcevaErlotinib HydrochlorideOSI-774Radiation TherapyWhole Brain Radiation TherapyWBRT

Outcome Measures

Primary Outcomes (1)

  • Median Survival

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

    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)

  • Number of Participants With Overall Survival

    From date of registration until the date of first documented death or lost to follow up, whichever came first, assessed up to 2 years.

Study Arms (1)

Tarceva + RT

EXPERIMENTAL

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)Radiation: Radiation Therapy

Interventions

Tarceva (Erlotinib hydrochloride)DRUG

150 mg by mouth every day beginning Day 1.

Also known as: OSI-774
Tarceva + RT
Radiation TherapyRADIATION

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

Also known as: RT, XRT, Radiotherapy
Tarceva + RT

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arizona

Tucson, Arizona, 85721, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 23341526DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungBrain NeoplasmsLung Neoplasms

Interventions

Erlotinib HydrochlorideRadiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTherapeutics

Results Point of Contact

Title
James Welsh,MD- Associate Professor, Radiation Oncology Department
Organization
UT MD Anderson Cancer Center
jwelsh@mdanderson.org
(713) 563-2447

Study Officials

  • James Welsh, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 30, 2009

Study Start

March 26, 2009

Primary Completion

December 4, 2019

Study Completion

December 4, 2019

Last Updated

September 16, 2021

Results First Posted

September 16, 2021

Record last verified: 2021-09

Locations

US(2)