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Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.



- 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.


- 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.

Inclusion Criteria


- 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)


- 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

- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Major objective response rate (complete response and partial response)

Outcome Description:

Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions

Outcome Time Frame:

At 4 weeks and then every 8 weeks

Safety Issue:


Principal Investigator

William Pao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:

VCC THO 0214



Start Date:

July 2002

Completion Date:

March 2013

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • bronchoalveolar cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



MD Anderson Cancer Center Houston, Texas  77030-4096
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Northwestern Memorial Hospital Chicago, Illinois  60611