Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

Vanderbilt University Medical Center

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: erlotinib hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00416650

VU-VCC-IRB-02-0168

GENENTECH-VU-VCC-THO-0214

P30CA068485 (U.S. NIH Grant/Contract)

P50CA090949 (U.S. NIH Grant/Contract)

VU-VCC-THO-0214

VCC THO 0214

Details and patient eligibility

About

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer.

Full description

OBJECTIVES:

Primary

• Determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride.

Secondary

• Assess the quality of life of patients treated with this regimen.
• Determine the duration of response and time to disease progression in patients treated with this regimen.
• Determine the median survival of patients treated with this regimen.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)

  • Stage IIIB (malignant pleural or pericardial effusion) disease
  • Stage IV disease
  • Recurrent and/or medically inoperable disease

• Measurable or evaluable indicator lesions

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

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%

• Life expectancy ≥ 8 weeks

• WBC ≥ 3,000/mm³

• Hemoglobin ≥ 9.0 g/dL

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 1.0 mg/dL

• AST ≤ 2 times upper limit of normal

• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No significant medical history or unstable medical condition, including any of the following:

  • Unstable systemic disease
  • Congestive heart failure
  • Recent myocardial infarction
  • Unstable angina
  • Active infection
  • Uncontrolled hypertension

• No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 3 weeks since prior radiation therapy to a major bone marrow-containing area
• At least 3 weeks since prior chemotherapy
• No more than 1 prior chemotherapy regimen for NSCLC
• No prior systemic cytotoxic chemotherapy for other malignant diseases
• No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab [Herceptin®], or gefitinib)
• No concurrent radiotherapy or chemotherapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Therapeutic Intervention

Experimental group

Description:

Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.

Treatment:

Drug: erlotinib hydrochloride