Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

NCT ID: NCT00085280

Last Updated: 2014-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Prospectively identify downstream markers of EGFR linked signaling pathways that are predictive of response to OSI-774 (Erlotinib) in this population.

SECONDARY OBJECTIVES:

I. Estimate antitumor objective response rate per RECIST. II. Estimate disease control rate (CR+PR+SD). III. Estimate time to progression and overall survival. IV. Estimate if a grade 2 rash is a predictor of response to OSI-774 (Erlotinib) and of patient survival.

V. Assess safety profile of OSI-774 (Erlotinib) in this population. VI. To determine whether smoking status is linked to outcome for advanced NSCLC patients treated with OSI-774 (Erlotinib).

OUTLINE: This is a pilot, multicenter study.

Patients 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.

After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 129 patients will be accrued for this study within 6 months.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (erlotinib hydrochloride)

Patients 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.

Group Type: EXPERIMENTAL

erlotinib hydrochloride

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

erlotinib hydrochloride

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CP-358,774; erlotinib; OSI-774

Eligibility Criteria

Inclusion Criteria

• 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
• Pregnant and breast feeding women are excluded from the study because the agent used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk
• Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) for the duration of the study
• HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774 (Erlotinib)
• Patients must not have had immuno, hormonal or radiation therapy within 2 weeks prior to entering the study; those who have not recovered from adverse events due to agents administered more than 2 weeks earlier are ineligible; previously irradiated areas can be considered "measurable disease" if there has been documented progression
• Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
• Patients must not have serious non-healing wound, or bone fracture, or major surgical procedure within 21 days prior to study entry
• Patients taking Warfarin are eligible
• If the patient is taking Cyp3A4 inducers or inhibitors, they must be discontinued one week prior to starting OSI-774 (Erlotinib)
• Patients must not be enrolled in any other concurrent clinical trials

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Brahmer

Role: PRINCIPAL_INVESTIGATOR

Eastern Cooperative Oncology Group

Locations

Eastern Cooperative Oncology Group

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24246704 (View on PubMed)

Other Identifiers

NCI-2012-03147

Identifier Type: REGISTRY

Identifier Source: secondary_id

U10CA021115

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000368459

Identifier Type: -

Identifier Source: secondary_id

ECOG-E3503

Identifier Type: -

Identifier Source: secondary_id

E3503

Identifier Type: OTHER

Identifier Source: secondary_id

E3503

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-03147

Identifier Type: -

Identifier Source: org_study_id