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Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for 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: NCT00103051
Recruitment Status : Completed
First Posted : February 8, 2005
Last Update Posted : July 16, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and cisplatin together with gefitinib before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with gefitinib works 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: gefitinib Drug: gemcitabine hydrochloride Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Detailed Description:



  • Determine the therapeutic activity of neoadjuvant induction therapy comprising gemcitabine, cisplatin, and gefitinib in patients with stage IIIA non-small cell lung cancer undergoing surgery.


  • Determine the safety profile of this regimen in these patients.
  • Determine the stage downsizing and complete resectability rate in patients with no progressive disease who undergo surgery after treatment with this regimen.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive induction therapy comprising gemcitabine IV over 30 minutes on days 1, 8, 22, 29, 43, and 50; cisplatin IV over 3-6 hours on days 2, 23, and 44; and oral gefitinib once daily on days 51-79. Treatment continues in the absence of disease progression or unacceptable toxicity. Within 2-7 days after completion of induction therapy, patients with no progressive disease undergo tumor resection.

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

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study With Gefitinib (Sequentially) Following Gemcitabine/Cisplatin as Induction Regimen for Patients With Stage IIIA N2 NSCLC
Study Start Date : December 2004
Actual Primary Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Complete response rate as measured by RECIST criteria prior to surgery

Secondary Outcome Measures :
  1. Overall response rate as measured by RECIST criteria prior to surgery
  2. Toxicity as assessed by CTC

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed primary non-small cell lung cancer (NSCLC)

    • Clinical stage IIIA by chest CT scan
    • Unresectable N2 disease by mediastinoscopy, mediastinotomy, thoracotomy, or video-assisted thoracic surgery
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • Planning to undergo lobectomy or pneumonectomy after induction therapy
  • No N3 or metastatic disease by physical exam, thoracic CT scan, bone scan, and CT scan or ultrasound of the liver and adrenal glands
  • No pleural or pericardial effusion
  • No superior vena cava syndrome
  • No diffuse interstitial pulmonary fibrosis
  • No signs or symptoms of CNS involvement



  • Over 18

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3


  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • Alkaline phosphatase ≤ 2.5 times ULN


  • Creatinine ≤ 1.25 times ULN
  • Creatinine clearance ≥ 60 mL/min


  • No medically uncontrolled congestive heart failure or angina pectoris
  • No uncontrolled hypertension or arrhythmia
  • No myocardial infarction within the past year


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Physically and mentally fit to receive gemcitabine- and cisplatin-containing chemotherapy
  • Physiologically fit to undergo surgery
  • No uncontrolled, active infection requiring IV antibiotics
  • No history of hypersensitivity to gefitinib or any of its excipients
  • No motor or sensory neurotoxicity ≥ grade 2
  • No other primary malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer

    • No prior melanoma, breast cancer, or renal cell cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance


Biologic therapy

  • No concurrent immunotherapy


  • No prior chemotherapy for NSCLC
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent antiestrogen therapy
  • Concurrent replacement steroids and antiemetic steroids allowed


  • No prior radiotherapy for NSCLC


  • See Disease Characteristics
  • No prior surgery for NSCLC


  • More than 1 month since prior and no concurrent investigational agents
  • No other prior therapy for NSCLC
  • No concurrent CYP3A4 inducers, including any of the following:

    • Phenytoin
    • Carbamazepine
    • Rifampin
    • Barbiturates (e.g., phenobarbital)
    • Hypericum perforatum (St. John's wort)
  • No concurrent systemic retinoids
  • No other concurrent antitumor therapy

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): NCT00103051

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Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Nico Van Zandwijk, MD, PhD The Netherlands Cancer Institute

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00103051    
Other Study ID Numbers: EORTC-08013
2004-001332-23 ( EudraCT Number )
First Posted: February 8, 2005    Key Record Dates
Last Update Posted: July 16, 2012
Last Verified: July 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IIIA non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
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