Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
A Pilot Study to Determine if Downstream Markers of EGFR Linked Signaling Pathways Predict Response to OSI-774 (Erlotinib) in the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
5 other identifiers
interventional
129
1 country
1
Brief Summary
This clinical trial is studying how well erlotinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 10, 2004
CompletedFirst Posted
Study publicly available on registry
June 11, 2004
CompletedStudy Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedMarch 31, 2014
January 1, 2013
2.1 years
June 10, 2004
March 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Response rates and distribution of the mitogen-activated protein kinase (MAPK)/extracellular-signal-regulated kinase (Erk)-phosphorylated expression groups based on the Response Evaluation Criteria in Solid Tumors (RECIST)
A Fisher's exact test with a two-sided 5% type I error rate will be calculated.
Up to 5 years
Secondary Outcomes (7)
Objective response rate based on the RECIST
Up to 5 years
Disease control rate (complete response [CR]+partial response [PR]+stable disease [SD])
Up to 8 weeks
Time to progression
Date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, up to 5 years
Overall survival
Up to 5 years
Toxicities associated with erlotinib hydrochloride, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Up to 5 years
- +2 more secondary outcomes
Study Arms (1)
Treatment (erlotinib hydrochloride)
EXPERIMENTALPatients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment.
Interventions
Given orally
Eligibility Criteria
You may qualify if:
- Patients must have pathologically confirmed NSCLC
- Patients must have diagnostic specimen available on paraffin-embedded block
- Patients must have advanced NSCLC (stage IIIB with a malignant pleural effusion or IV disease, or recurrent disease)
- Patients must not have received prior chemotherapy or targeted therapy for metastatic disease, including no prior EGFR inhibitor; patient may have received adjuvant chemotherapy for early stage disease (IB-IIIA), or chemo/XRT for stage IIIA or IIIB disease, provided s/he meets all of the following:
- It has been at least 6 months since completion of patient's adjuvant chemotherapy for early stage disease (IB-IIIA) or chemo/XRT for stage IIIA or IIIB disease
- Patient now has advanced disease
- Patients must have measurable disease per RECIST criteria; all sites of disease must be assessed within 4 weeks prior to registration
- Creatinine \< 1.5 mg/dL or a creatinine clearance of \> 50 mL/min
- SGOT(AST) and SGPT(ALT) \< 2 x the institution's upper limit of normal
- Bilirubin \< 1.5 mg/dL
- ANC \> 1500/mm\^3
- PLT \> 100,000/mm\^3
- Patients must have ECOG performance status 0, 1, or 2
- Patients with stable, treated brain metastases are eligible (defined as: patients with brain metastases must have been treated and are asymptomatic and are no longer taking corticosteroids)
- Patients with gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease, are ineligible
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215, United States
Related Publications (1)
Brahmer JR, Lee JW, Traynor AM, Hidalgo MM, Kolesar JM, Siegfried JM, Guaglianone PP, Patel JD, Keppen MD, Schiller JH. Dosing to rash: a phase II trial of the first-line erlotinib for patients with advanced non-small-cell lung cancer an Eastern Cooperative Oncology Group Study (E3503). Eur J Cancer. 2014 Jan;50(2):302-8. doi: 10.1016/j.ejca.2013.10.006. Epub 2013 Nov 15.
PMID: 24246704DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Brahmer
Eastern Cooperative Oncology Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2004
First Posted
June 11, 2004
Study Start
September 1, 2004
Primary Completion
October 1, 2006
Last Updated
March 31, 2014
Record last verified: 2013-01