NCT00047736

Brief Summary

The purpose of this study is to determine if Tarceva plus standard chemotherapy is more effective than standard chemotherapy alone in the treatment of lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2001

Shorter than P25 for phase_3 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

July 1, 2001

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

First QC Date

October 16, 2002

Last Update Submit

June 19, 2013

Conditions

Lung Cancer

Keywords

Non-small cell lung cancer

Interventions

Tarceva (erlotinib HCl)DRUG

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • Age \>=18 years
  • Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NSCLC)
  • A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
  • Measurable or non-measurable disease
  • ECOG performance status of 0 or 1
  • Life expectancy of \>=3 months
  • \>= 3 weeks since any prior surgery or radiotherapy (\>=2 weeks for patients who receive \<=30 Gy of radiotherapy involving \<25% of the marrow reserve)
  • Use of an effective means of contraception (women of childbearing potential)
  • Able to comply with study and follow-up procedures

You may not qualify if:

  • Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology
  • Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
  • Symptomatic or untreated brain metastases
  • Prior systemic chemotherapy for NSCLC
  • Prior exposure to agents directed at the HER axis (e.g., ZD1839 \[Iressa\], C225 \[Cetuximab\], Trastuzumab \[Herceptin\])
  • Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible)
  • History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
  • Pregnancy or lactation
  • Any of the following abnormal baseline hematologic values:
  • Granulocytes count \<=1500/uL
  • Platelet count \<100,000/uL
  • Any of the following abnormal baseline liver function tests:
  • Serum bilirubin \>1.5× upper limit of normal (ULN)
  • Serum ALT and AST \>=2.5× ULN (\>5× ULN if due to liver metastases)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Multinational Sites

Denver, Colorado, United States

Location

Trial Information Center

Denver, Colorado, United States

Location

Related Publications (1)

  • Hirsch FR, Varella-Garcia M, Dziadziuszko R, Xiao Y, Gajapathy S, Skokan M, Lin M, O'Neill V, Bunn PA Jr. Fluorescence in situ hybridization subgroup analysis of TRIBUTE, a phase III trial of erlotinib plus carboplatin and paclitaxel in non-small cell lung cancer. Clin Cancer Res. 2008 Oct 1;14(19):6317-23. doi: 10.1158/1078-0432.CCR-08-0539.

    PMID: 18829515RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2002

First Posted

October 17, 2002

Study Start

July 1, 2001

Study Completion

July 1, 2003

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

US(2)