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