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 some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving erlotinib alone or together with carboplatin and paclitaxel works in treating patients with stage III or stage IV non-small cell lung cancer.

Further Study Information

OBJECTIVES:

Primary

• Determine the progression-free survival of patients with chemotherapy-naïve select stage IIIB or stage IV non-small cell lung cancer treated with erlotinib with or without carboplatin and paclitaxel.

Secondary

• Determine the radiographic response rate in patients treated with these regimens.

• Correlate the frequency of epidermal growth factor receptor (EGFR) mutations, K-ras mutations, and ALK translocations with the response rate and time to progression in patients treated with these regimens.

• Determine the median and overall survival of patients treated with these regimens.

• Correlate the response rate, progression-free survival, and overall survival with EML4-ALK translocation in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.

After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 180 patients (80 for arm I and 100 for arm II) will be accrued for this study within 1.5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

• Adenocarcinoma histology, including any of the following histologic variants:

• Pure or mixed bronchoalveolar cell carcinoma

• Adenosquamous cell carcinoma

• No NSCLC not otherwise specified

• Pathology block or unstained slides from initial or subsequent diagnosis available

• At least a core biopsy required

• Fine needle aspirate alone is not sufficient

• Meets 1 of the following stage criteria:

• Select stage IIIB disease with cytologically documented malignant pleural or pericardial effusion

• Stage IV disease

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• The following are considered non-measurable disease:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural or pericardial effusion

• Lymphangitis cutis/pulmonis

• Abdominal masses not confirmed and followed by imaging techniques

• Cystic lesions

• Meets 1 of the following criteria for smoking history:

• Non-smoker, defined as a person who smoked ≤ 100 cigarettes in their lifetime

• Former light smoker, defined as a person who smoked ≤ 10 pack years AND quit smoking ≥ 1 year ago

• No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requires corticosteroids)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

Hepatic

• AST ≤ 2.5 times upper limit of normal (ULN)

• Total bilirubin ≤ ULN

Renal

• Creatinine ≤ 1.5 mg/dL

Gastrointestinal

• Able to swallow tablets intact or dissolved in water

• No dysphagia

• No active gastrointestinal disease or disorder that would alter gastrointestinal motility or absorption

• No lack of integrity of the gastrointestinal tract

Other

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior trastuzumab (Herceptin®) or cetuximab

Chemotherapy

• No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

• No concurrent hormonal therapy except for the following:

• Hormones for non-disease-related conditions (e.g., insulin for diabetes)

• Steroids for adrenal failure

• Intermittent use of dexamethasone as an antiemetic or to prevent paclitaxel hypersensitivity reactions

Radiotherapy

• At least 3 weeks since prior radiotherapy, including cranial irradiation

• No concurrent radiotherapy, including palliative radiotherapy

Surgery

• At least 3 weeks since prior major surgery

• No prior significant surgical resection of the stomach or small bowel

Other

• No prior erlotinib, gefitinib, or lapatinib

• No other prior treatment targeting the HER family axis

• More than 4 weeks since prior and no other concurrent investigational agents

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Pasi Janne

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00126581
Information obtained from ClinicalTrials.gov on December 14, 2011

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