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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: erlotinib hydrochloride

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Intervention; Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.	Drug: erlotinib hydrochloride; All patients will receive 150 mg orally daily; Other Names: Tarceva, OSI-774

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major objective response rate (complete response and partial response)	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	At 4 weeks and then every 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst grade toxicity	Number of patients with worst-grade toxicity at each of five grades (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death) following NCI Common Toxicity Criteria, v. 2. Drug is discontinued for disease progression, unacceptable toxicity, patient undergoes radiation or other chemotherapy, or withdraws from study	weekly for 4 weeks, then every 8 weeks to discontinuation of drug
Quality of life as measured by the Lung Cancer Symptom Scale for patients	The Lung Cancer Symptom Scale for patients is a nine-item scale with 0 = lowest rating (least) to 100 = highest rating (worst) for the measurement of symptom burden for loss of appetite, fatigue, cough, dyspnea, hemoptysis, activity, quality of life, lung cancer symptoms, and pain.	baseline, every week for 5 weeks, and then every 4 weeks
Survival	Duration of time from date of study entry to death from any cause or to the last date the patient is known to be alive.	from study entry to date of death or last date known alive

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: William Pao, MD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 27, 2006
• First Submitted That Met QC Criteria: December 27, 2006
• First Posted (Estimate): December 28, 2006

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 2, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; bronchoalveolar cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: VCC THO 0214; P30CA068485 (U.S. NIH Grant/Contract); P50CA090949 (U.S. NIH Grant/Contract); VU-VCC-THO-0214; VU-VCC-IRB-02-0168; GENENTECH-VU-VCC-THO-0214