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Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00062270
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : October 8, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Alabama at Birmingham

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: docetaxel Drug: gefitinib Drug: gemcitabine hydrochloride Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:


  • Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer.

Phase II:

  • Compare the pathologic response (complete response and rate of downstaging) in patients treated with neoadjuvant chemoradiotherapy with vs without gefitinib.
  • Compare the feasibility and toxicity profile of these regimens in these patients.
  • Compare the resection rates, time to progression, and overall survival of patients treated with these regimens.
  • Correlate the percent decline in the fludeoxyglucose F 18 standardized uptake value as measured by position emission tomography with pathologic response at resection, time to progression, and overall survival in patients treated with these regimens.


  • Phase I: This is an open-label, nonrandomized study.

    • Induction: Patients receive cisplatin IV over 60 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity.
    • Consolidation: Within 3-4 weeks after the completion of induction therapy, patients undergo radiotherapy once daily 5 days a week for 5 weeks and receive oral gefitinib once daily concurrently.

A cohort of 3-6 patients receives consolidation chemoradiotherapy. If 2 of 6 patients experience dose-limiting toxicity, gefitinib is deleted from consolidation therapy in phase II arm II.

  • Surgery: Patients without disease progression after consolidation therapy undergo thoracotomy within 3-5 weeks after consolidation.
  • Maintenance: Beginning 2-4 weeks after surgery, patients receive oral gefitinib once daily for 6 months in the absence of disease progression.

    • Phase II: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive induction and consolidation therapy (with the exception of gefitinib) as in phase I. Patients also receive docetaxel IV over 60 minutes concurrently with radiotherapy during consolidation. Patients undergo surgery as in phase I.
  • Arm II: Patients receive therapy (including gefitinib) as in phase I. Patients also receive docetaxel IV over 60 minutes concurrently with radiotherapy during consolidation.

Patients are followed every 6-8 weeks for the first 12 months and then every 4-6 months thereafter.

PROJECTED ACCRUAL: A total of 43-80 patients (3-6 patients for phase I and 40-74 patients [20-37 per treatment arm] for phase II) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemoradiotherapy (Gemcitabine/Cisplatin and Taxotere) With or Without Co-Administration of ZD 1839 (Iressa) for Stage IIIA (N2) and Selective Stage IIIB Non-Small Cell Lung Cancer: Phase I-II Study
Study Start Date : May 2003
Primary Completion Date : September 2004
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Primary Outcome Measures :
  1. Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer

    • Stage IIIA (T1-3, N2)

      • Positive (pathological) ipsilateral mediastinal node
    • Selective stage IIIB meeting all of the following criteria:

      • No pleural/pericardial effusion or superior vena cava syndrome
      • T4 due to invasion of carina, trachea, or mediastinal structures
      • Mediastinal N3 nodes (without supraclavicular or cervical adenopathy)
  • Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration)
  • Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry
  • Measurable disease by contrast CT scan allowed
  • No bronchoalveolar cell carcinoma
  • No prior diagnosis of lung cancer



  • 19 and over

Performance status

  • ECOG 0-1 (0-2 if albumin is at least 0.85 times lower limit of normal and weight loss within 3 months before diagnosis is no greater than 10%)

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN

    • Alkaline phosphatase between 1.5-2 times ULN requires a negative bone scan for metastatic bone disease


  • Creatinine no greater than 1.4 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • No myocardial infarction within the past 3 months
  • No active angina
  • No unstable heart rhythms
  • No congestive heart failure


  • Post-resection predicted FEV_1% greater than 35%

    • Predicted FEV_1% is defined as FEV_1% times percent perfusion to uninvolved lung from quantitative lung V/Q scan report


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 weeks after study treatment
  • No other uncontrolled medical illness
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No grade 2 or greater peripheral neuropathy
  • No concurrent ocular inflammation or infection
  • No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No known severe hypersensitivity reaction to gefitinib or any of its excipients
  • No prior severe allergic reaction to platinum-containing compounds or mannitol


Biologic therapy

  • No concurrent growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during chemotherapy


  • No prior chemotherapy for lung cancer

Endocrine therapy

  • Not specified


  • No prior radiotherapy for lung cancer


  • Recovered from prior major surgery
  • No concurrent ophthalmic surgery


  • More than 30 days since prior unapproved or investigational drugs
  • No concurrent use of the following drugs:

    • Phenytoin
    • Carbamazepine
    • Barbiturates
    • Rifampin
    • Phenobarbital
    • Hypericum perforatum (St. John's Wort)
    • Warfarin
  • No concurrent retinoids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062270

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study Chair: Francisco Robert, MD, FACP University of Alabama at Birmingham

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00062270     History of Changes
Other Study ID Numbers: CDR0000304674
First Posted: June 6, 2003    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: September 2015

Keywords provided by University of Alabama at Birmingham:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors