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Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lecia V. Sequist, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00411047
First received: December 11, 2006
Last updated: May 12, 2013
Last verified: May 2013
  Purpose

RATIONALE: Gefitinib 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 gefitinib works in treating patients with previously untreated stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open Label Study of Gefitinib (IRESSA) in Treatment-Naïve Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer and Somatic Activating Mutations in the Epidermal Growth Factor Receptor

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Objective tumor response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response duration, progression-free survival, and overall survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Ability of various somatic activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene to predict response and toxicity [ Designated as safety issue: Yes ]
  • Molecular profile [ Designated as safety issue: No ]
  • Significance of germline polymorphisms of the EGFR gene, somatic amplification of the EGFR gene, and other molecular factors for their association with clinical outcome parameters [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: September 2005
Study Completion Date: December 2012
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: gefitinib
    oral drug taken daily around the same time
    Other Name: IRESSA
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective tumor response rate in patients with previously untreated stage IIIB or IV non-small cell lung cancer with somatic activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene treated with gefitinib.

Secondary

  • Determine response duration, progression-free survival, and overall survival of patients treated with this drug.
  • Determine the safety of this drug in these patients.
  • Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict response in patients treated with this drug.
  • Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict toxicity of this drug in these patients.
  • Define a molecular profile in patients who initially respond to treatment with this drug but subsequently progress on therapy.
  • Determine the significance of germline polymorphisms of the EGFR gene, somatic amplification of the EGFR gene, and other molecular factors for their association with clinical outcome parameters in these patients.

OUTLINE: This is an open-label study.

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically confirmed non-small cell lung cancer (NSCLC)

    • No squamous cell histology
  • Stage IIIB (with pleural effusion) or stage IV disease
  • Must meet ≥ 1 of the following criteria:

    • Female
    • Adenocarcinoma tumor histology
    • No history of smoking, defined as smoking < 100 cigarettes (5 standard packs of cigarettes) in a lifetime, < 20 oz of pipe tobacco in a lifetime, OR < 100 cigars in a lifetime
    • Asian/Pacific Rim ethnicity, defined as Japanese, Chinese, Korean, or other Asian/Pacific Rim ethnicity
  • Must have activating mutations in the TK region of the epidermal growth factor receptor (EGFR) gene
  • Measurable disease
  • No symptomatic or newly diagnosed CNS metastases that have not been definitively treated with radiotherapy and/or surgery

    • History of CNS metastases or cord compression allowed if definitively treated and clinically stable

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count ≥ 2,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.25 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (5 times ULN if liver has tumor involvement)
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known severe hypersensitivity to gefitinib or any other component of gefitinib tablets
  • No evidence of clinically active interstitial lung disease

    • Patients with chronic, stable radiographic changes who are asymptomatic are eligible
  • No other concurrent malignancy or malignancy diagnosed within the past 5 years except for basal cell carcinoma of the skin or cervical cancer in situ
  • No concurrent severe or uncontrolled systemic disorder
  • No evidence of any other significant clinical disorder or laboratory finding that, in the opinion of the investigator, would preclude study participation
  • Able to tolerate protocol treatment, in the opinion of the investigator

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy, biological therapy, immunotherapy, or hormonal therapy for NSCLC, including adjuvant and neoadjuvant treatment
  • No prior radiotherapy to the target lesion

    • Prior radiotherapy to bony disease or CNS disease allowed
  • At least 2 weeks since prior radiotherapy and recovered
  • More than 30 days since prior non-FDA approved or investigational agents
  • No prior EGFR antagonists
  • At least 2 weeks since prior and no concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort)
  • No concurrent chemotherapy, immunotherapy, hormonal therapy, nonpalliative radiotherapy, surgery for cancer, or other experimental medications
  • No other concurrent specific antitumor therapy
  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: NCT00411047

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Lecia V Sequist, MD, MPH Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Lecia V. Sequist, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00411047     History of Changes
Other Study ID Numbers: 04-291, IRUSIRES0483
Study First Received: December 11, 2006
Last Updated: May 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
large cell lung cancer

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

ClinicalTrials.gov processed this record on November 24, 2014