Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
- Conditions
- Recurrent Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung Cancer
- Interventions
- Other: laboratory biomarker analysis
- Registration Number
- NCT00085280
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
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Patients must have pathologically confirmed NSCLC
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Patients must have diagnostic specimen available on paraffin-embedded block
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Patients must have advanced NSCLC (stage IIIB with a malignant pleural effusion or IV disease, or recurrent disease)
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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
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Patients must have measurable disease per RECIST criteria; all sites of disease must be assessed within 4 weeks prior to registration
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Creatinine < 1.5 mg/dL or a creatinine clearance of > 50 mL/min
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SGOT(AST) and SGPT(ALT) < 2 x the institution's upper limit of normal
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Bilirubin < 1.5 mg/dL
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ANC > 1500/mm^3
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PLT > 100,000/mm^3
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Patients must have ECOG performance status 0, 1, or 2
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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)
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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
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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
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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
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HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774 (Erlotinib)
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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
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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
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Patients must not have serious non-healing wound, or bone fracture, or major surgical procedure within 21 days prior to study entry
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Patients taking Warfarin are eligible
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If the patient is taking Cyp3A4 inducers or inhibitors, they must be discontinued one week prior to starting OSI-774 (Erlotinib)
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Patients must not be enrolled in any other concurrent clinical trials
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (erlotinib hydrochloride) 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. Treatment (erlotinib hydrochloride) laboratory biomarker analysis 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.
- Primary Outcome Measures
Name Time Method 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) Up to 5 years A Fisher's exact test with a two-sided 5% type I error rate will be calculated.
- Secondary Outcome Measures
Name Time Method 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 Relationship between clinical response and each of the markers using the semiquantitative histo-score method Baseline Cox regression models will be used.
Effects of smoking status in terms of disease and survival Up to 5 years Descriptive and summary statistics will be conducted on the smoking questionnaire data.
Objective response rate based on the RECIST Up to 5 years
Trial Locations
- Locations (1)
Eastern Cooperative Oncology Group
🇺🇸Boston, Massachusetts, United States