Status:
COMPLETED
Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 blocki...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00085280
Start Date
September 1 2004
Last Update
March 31 2014
Active Locations (1)
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1
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215