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Gefitinib, Docetaxel, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00310154
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : May 30, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib together with docetaxel and radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with gefitinib and radiation therapy in treating patients with stage III non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: docetaxel Drug: gefitinib Other: laboratory biomarker analysis Radiation: radiation therapy Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of docetaxel that can be safely delivered in combination with gefitinib and a definitive course of 3-D planned thoracic radiotherapy in patients with stage III non-small cell lung cancer.

OUTLINE: This is a dose-escalation study of docetaxel.

  • Chemoradiotherapy: Patients receive concurrent chemoradiotherapy comprising docetaxel IV over 30 minutes on day 1 and thoracic radiotherapy once daily on days 1-5 in weeks 1-7 in the absence of disease progression or unacceptable toxicity.
  • Consolidation chemotherapy: Beginning 2 weeks after the completion of chemoradiotherapy, patients receive consolidation chemotherapy comprising docetaxel IV over 60 minutes on days 1 and 22.
  • Gefitinib therapy: Patients also receive oral gefitinib once daily beginning at the start of chemoradiotherapy and continuing for up to 1 year* in the absence of disease progression.

NOTE: *Patients continue to receive gefitinib during the 2-week rest period between chemoradiotherapy and consolidation chemotherapy.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Tumor tissue is tested to determine correlation between epidermal growth factor receptor presence and response to treatment.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 45 patients will be accrued in this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ZD-1839 (Iressa®) With Concurrent Docetaxel and Conformal Three Dimensional Thoracic Radiation Followed by Consolidative Docetaxel and ZD-1839 for Patients With Stage III Non Small Cell Lung Cancer: A Phase I Study
Study Start Date : November 2003
Actual Primary Completion Date : July 2007
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. To determine the feasability of daily ZD1839 delivered with concurrent 3-dimensional planned thoracic radiation [ Time Frame: baseline to 2 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following:

    • Squamous cell carcinoma
    • Adenocarcinoma (including bronchoalveolar cell)
    • Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
  • Stage IIIA/B disease

    • Unresectable disease
    • Tumors adjacent to a vertebral body allowed

      • No demonstrable bone invasion
      • All gross disease must be able to be encompassed in the radiation boost field in accordance with the homogeneity criteria
    • Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiation boost field in accordance with the homogeneity criteria

      • No scalene, supraclavicular, or contralateral hilar node involvement
    • Pleural effusion allowed if it is transudate, cytologically negative, and non-bloody AND tumor can be encompassed within a reasonable field of radiotherapy

      • No exudative, bloody, or cytologically malignant effusions
      • Pleural effusion seen on chest CT scan but not on chest x-ray and too small to tap allowed
  • Measurable disease, defined as lesions that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan

    • No nonmeasurable disease, including any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Tumor lesions situated in a previously irradiated area


  • ECOG performance status 0-1
  • Granulocyte count ≥ 1,500/mm^3
  • Hemoglobin > 8.0 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin < 1.5 mg/dL
  • Creatinine < 1.5 times upper limit of normal (ULN)
  • Meets 1 of the following criteria:

    • AST and ALT < 2 times ULN
    • AST and ALT ≤ 2.5 times ULN AND alkaline phosphatase (AP) normal
    • AST and ALT normal AND AP ≤ 4 times ULN
  • FEV_1 ≥ 1.2 L
  • No other currently active malignancy except nonmelanoma skin cancers

    • Patients are not considered to have another currently active malignancy if they have completed therapy for the other malignancy and are considered by their physician to be at < 30% risk of relapse (i.e., after treatment for early-stage prostate cancer)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after completing treatment
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No known severe hypersensitivity to gefitinib or any of the excipients of this product
  • No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • No evidence of any other significant clinical disorder or laboratory finding that would limit compliance with study requirements
  • No evidence of clinically active interstitial lung disease (asymptomatic, chronic stable radiographic changes allowed)
  • No peripheral neuropathy ≥ grade 1


  • At least 2 weeks since prior formal exploratory thoracotomy
  • No prior chemotherapy or radiotherapy for NSCLC
  • No prior epidermal growth factor-targeting drugs (i.e., gefitinib, erlotinib, or cetuximab)
  • No other investigational agent within 30 days of study entry
  • No concurrent phenytoin, carbamazepine, rifampicin, barbiturates, or Hypericum perforatum (St John's wort)
  • No other concurrent hormonal therapy or chemotherapy except for the following:

    • Steroids for adrenal failure, allergic reactions, or septic shock
    • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
    • Glucocorticosteroids as anti-emetics

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 identifier (NCT number): NCT00310154

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United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Study Chair: Arthur William Blackstock, MD Wake Forest University Health Sciences
Principal Investigator: Antonius A. Miller, MD Wake Forest University Health Sciences

Publications of Results:
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Responsible Party: Wake Forest University Health Sciences Identifier: NCT00310154     History of Changes
Other Study ID Numbers: CDR0000466391
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: November 2011

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
large cell lung cancer
squamous cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:
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Antimitotic Agents
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
Tubulin Modulators
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors