Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This clinical trial is studying how well erlotinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Further Study Information

OBJECTIVES:

Primary

• Determine downstream markers of epidermal growth factor receptor-linked signaling pathways that are predictive of response to erlotinib in patients with stage IIIB or IV or recurrent non-small cell lung cancer.

Secondary

• Determine antitumor objective response rate in patients treated with this drug.

• Determine disease control rate (complete response, partial response, or stable disease) in patients treated with this drug.

• Determine time to progression and overall survival of patients treated with this drug.

• Determine whether a grade 2 rash is a predictor of response to this drug and of survival of these patients.

• Determine the safety profile of this drug in these patients.

• Correlate smoking status, as measured by the Smoking Status Survey, with disease outcome and overall survival in patients treated with this drug.

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer (NSCLC)*

• Stage IIIB with malignant pleural effusion or IV or recurrent disease NOTE: *Must have diagnostic specimen available on paraffin-embedded block

• Measurable disease

• Previously irradiated areas are considered measurable if there is documented disease progression

• Stable, treated brain metastases allowed provided patients are asymptomatic and not taking corticosteroids

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

Hepatic

• AST and ALT < 2 times upper limit of normal

• Bilirubin < 1.5 mg/dL

Renal

• Creatinine < 1.5 mg/dL OR

• Creatinine clearance > 50 mL/min

Cardiovascular

• No unstable angina pectoris

• No symptomatic congestive heart failure

• No symptomatic cardiac arrhythmia

Gastrointestinal

• No requirement for IV alimentation

• No active peptic ulcer disease

• No gastrointestinal tract disease resulting in an inability to take oral medication

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No bone fracture

• No serious non-healing wound

• No active or ongoing infection

• No psychiatric illness that would preclude study compliance

• No comorbidity that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 2 weeks since prior immunotherapy and recovered

• No concurrent routine myeloid growth factors

Chemotherapy

• No prior chemotherapy for metastatic disease

• Prior adjuvant chemotherapy for stage IB-IIIA disease OR chemoradiotherapy for stage IIIA or IIIB disease allowed provided both of the following criteria are met:

• Prior treatment completed ≥ 6 months ago

• Patient now presents with advanced disease

Endocrine therapy

• See Disease Characteristics

• More than 2 weeks since prior hormonal therapy and recovered

Radiotherapy

• See Disease Characteristics

• See Chemotherapy

• More than 2 weeks since prior radiotherapy and recovered

Surgery

• More than 21 days since prior major surgical procedure

• No prior surgical procedure affecting absorption

Other

• No prior epidermal growth factor receptor inhibitors

• No prior targeted therapy for metastatic disease

• At least 1 week since prior CYP3A4 inducers or inhibitors

• Concurrent warfarin allowed

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent grapefruit juice

• No concurrent enrollment in any other clinical trial

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Julie Brahmer

Study Chair

Anne M. Traynor

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00085280
Information obtained from ClinicalTrials.gov on December 14, 2011

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