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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University Identifier:
First received: March 29, 2006
Last updated: November 30, 2011
Last verified: November 2011

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 Intervention Phase
Lung Cancer
Drug: docetaxel
Drug: gefitinib
Other: laboratory biomarker analysis
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • To determine the feasability of daily ZD1839 delivered with concurrent 3-dimensional planned thoracic radiation [ Time Frame: baseline to 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: November 2003
Study Completion Date: August 2010
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00310154

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

Responsible Party: Comprehensive Cancer Center of Wake Forest University Identifier: NCT00310154     History of Changes
Other Study ID Numbers: CDR0000466391  P30CA012197  CCCWFU-62202  ZENECA-IRUSIRES0043  CCCWFU-BG03-310 
Study First Received: March 29, 2006
Last Updated: November 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antimitotic Agents
Antineoplastic Agents
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators processed this record on May 03, 2016