Study 19 of 6183 for search of: United States, Illinois
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Gefitinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00029003
  Purpose

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of non-small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: gefitinib
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: ZD1839
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial Of Chronic Oral ZD 1839 (IRESSA) (NSC-715055) In Both Previously-Untreated And Previously-Treated Patients With Selected Stage IIIB And IV Bronchioloalveolar Carcinoma (BAC)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2001
Detailed Description:

OBJECTIVES:

  • Determine the 1-year survival, progression-free survival, and overall survival of patients with stage IIIB or IV bronchoalveolar carcinoma treated with gefitinib.
  • Determine the frequency and severity of toxic effects of this drug in these patients.
  • Determine the response rate in patients with measurable disease treated with this drug.
  • Correlate epidermal growth factor receptor (EGFR) and EGFR variant III overexpression with clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic treatment for bronchoalveolar carcinoma (yes vs no). (The previously untreated stratum closed to accrual as of 2/15/2003.)

Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 90 patients (55 for the previously untreated stratum and 35 for the previously treated stratum) will be accrued for this study within 24 months. (The previously untreated stratum closed to accrual as of 2/15/2003.)

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed bronchoalveolar carcinoma

    • No fine needle aspirates or bronchial brushings or washings
    • Multi-focal or diffuse tumors
  • Stage IIIB disease due to cytologically confirmed malignant pleural effusion OR
  • Stage IV disease
  • Evidence of disease by CT scan of chest
  • Incompletely resected or unresectable disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if bone metastases present)

Renal:

  • Not specified

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No uncontrolled concurrent illness
  • No ongoing or active infection
  • No gastrointestinal tract disease that would preclude oral medication intake or cause requirement for IV alimentation
  • No corneal inflammation or infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy
  • No prior biologic therapy that targets epidermal growth factor receptor

Chemotherapy:

  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to areas of assessable disease

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery
  • No prior surgical procedure affecting gastrointestinal absorption

Other:

  • No other concurrent therapy for bronchoalveolar carcinoma
  • No other concurrent investigational agents
  • No concurrent agents that induce CYP3A4 (e.g., nafcillin, rifampin, carbamazepine, phenobarbital, phenytoin, and St. John's wort)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029003

  Show 98 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Howard L. West, MD Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
West H, Chansky K, Franklin WA, et al.: Long-term survival with gefitinib (ZD 1839) therapy for advanced bronchioloalveolar lung cancer (BAC): Southwest Oncology Group (SWOG) study S0126. [Abstract] J Clin Oncol 26 (Suppl 15): A-8047, 2008.
West HL, Franklin WA, McCoy J, Gumerlock PH, Vance R, Lau DH, Chansky K, Crowley JJ, Gandara DR. Gefitinib therapy in advanced bronchioloalveolar carcinoma: Southwest Oncology Group Study S0126. J Clin Oncol. 2006 Apr 20;24(12):1807-13.
Gumerlock PH, Holland WS, Chen H, et al.: Mutational analysis of K-RAS and EGFR implicates K-RAS as a resistance marker in the Southwest Oncology Group (SWOG) trial S0126 of bronchioalveolar carcinoma (BAC) patients (pts) treated with gefitinib. [Abstract] J Clin Oncol 23 (Suppl 16): A-7008, 623s, 2005.
Hirsch FR, Gandara DR, McCoy J, et al.: Increased EGFR gene copy number detected by FISH is associated with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma (BAC) (S0126). [Abstract] J Clin Oncol 23 (Suppl 16): A-7030, 628s, 2005.
Hirsch FR, Varella-Garcia M, McCoy J, West H, Xavier AC, Gumerlock P, Bunn PA Jr, Franklin WA, Crowley J, Gandara DR; Southwest Oncology Group. Increased epidermal growth factor receptor gene copy number detected by fluorescence in situ hybridization associates with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma subtypes: a Southwest Oncology Group Study. J Clin Oncol. 2005 Oct 1;23(28):6838-45. Epub 2005 Jul 5.
West H, Franklin WA, Gumerlock PH, et al.: Gefitinib (ZD1839) therapy for advanced bronchioloalveolar lung cancer (BAC): Southwest Oncology Group (SWOG) study S0126. [Abstract] J Clin Oncol 22 (Suppl 14): A-7014, 620s, 2004.
West HL, Franklin WA, Gumerlock P, et al.: ZD1839 (Iressa) in advanced bronchioloalveolar carcinoma (BAC): a preliminary report of SWOG S0126. [Abstract] Lung Cancer 41 (Suppl 2): A-O-187, S56, 2003.

Other Publications:
Study ID Numbers: CDR0000069157, SWOG-S0126
Study First Received: January 4, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00029003  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
bronchoalveolar cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Gefitinib
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009