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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Pao, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00416650
First received: December 27, 2006
Last updated: April 2, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: erlotinib hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Major objective response rate (complete response and partial response) [ Time Frame: At 4 weeks and then every 8 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Worst grade toxicity [ Time Frame: weekly for 4 weeks, then every 8 weeks to discontinuation of drug ] [ Designated as safety issue: Yes ]
    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

  • Quality of life as measured by the Lung Cancer Symptom Scale for patients [ Time Frame: baseline, every week for 5 weeks, and then every 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Survival [ Time Frame: from study entry to date of death or last date known alive ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
Study Start Date: July 2002
Study Completion Date: March 2013
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Tarceva, OSI-774

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416650

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: William Pao, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: William Pao, MD, Professor of Medicine, Cancer Biology, & Pathology/ Microbiology/ Immunology; Director, Division of Hematology and Oncology; Ingram Professor of Cancer Research; Director, Personalized Cancer Medicine; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00416650     History of Changes
Other Study ID Numbers: VCC THO 0214, P50CA090949, P30CA068485, VU-VCC-THO-0214, VU-VCC-IRB-02-0168, GENENTECH-VU-VCC-THO-0214
Study First Received: December 27, 2006
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
bronchoalveolar cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014