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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	18 and over	NCI, Other	CDR0000368459 ECOG-E3503, NCT00085280

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 06, 2009

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