Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00103051
First received: February 7, 2005
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: gefitinib
Drug: gemcitabine hydrochloride
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Complete response rate as measured by RECIST criteria prior to surgery [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate as measured by RECIST criteria prior to surgery [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC [ Designated as safety issue: Yes ]

Study Start Date: December 2004
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Renal

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

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy for NSCLC
  • No other concurrent chemotherapy

Endocrine therapy

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

Radiotherapy

  • No prior radiotherapy for NSCLC

Surgery

  • See Disease Characteristics
  • No prior surgery for NSCLC

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103051

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

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00103051     History of Changes
Other Study ID Numbers: EORTC-08013, EORTC-08013, 2004-001332-23
Study First Received: February 7, 2005
Last Updated: July 13, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IIIA non-small cell lung cancer

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

ClinicalTrials.gov processed this record on April 16, 2014