Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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: NCT00536107
Recruitment Status : Terminated
First Posted : September 27, 2007
Results First Posted : October 1, 2013
Last Update Posted : October 1, 2013
Information provided by (Responsible Party):

Brief Summary:
This is a randomized, open- label, parallel group, phase IV, multicentre study. The total number of patients expected to be recruited is 40. These randomized patients will have a histologically or cytologically confirmed adenocarcinoma histology of locally advanced or metastatic NSCLC. Patients will be recruited by investigational sites that have expertise in treating patients with non-small cell lung cancer. The study will compare gefitinib monotherapy 250 mg/day orally with docetaxel 60 mg/m2 intravenously over 1 hour every 3 weeks with a primary endpoint of safety and tolerability. The target population will be patients who have received one prior platinum-based chemotherapy and are now considered suitable candidates for further chemotherapy with docetaxel. At study entry, patients will be randomized on a 1:1 basis stratified with respect to performance status (0-1 vs. 2). Patients may continue to receive treatment with either gefitinib or docetaxel until disease progression, unacceptable toxicity or the occurrence of any of the other specific criteria. An independent committee will be appointed to perform a blinded review of all patient scans. Any assessments/visits after screening should be performed within a window of plus or minus 3 working days of the scheduled visit date. If selected screening evaluations are done within 7 days of Day 1, Cycle 1 of treatment, and are acceptable for study entry, they do not have to be repeated on Day 1 unless the investigator believes that they are likely to have significantly changed. Any patient who discontinues from study treatment without radiological evidence of disease progression (except for withdrawal of consent by patient) should continue to have objective tumor assessments every 6 weeks in order to collect information on progression of disease

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Gefitinib Procedure: CT or MRI Drug: Docetaxel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized/Open Label/Parallel Group/Multicenter/Phase IV Study to Assess Safety/Tolerability/Efficacy of Oral Gefitinib 250 mg Versus IV Docetaxel 60 mg/m2 in Patients With Locally Advanced or Metastatic NSCL Cancer of Adenocarcinoma Histology Previous Treated With One Platinum Base Chemotherapy
Study Start Date : October 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Docetaxel
Procedure: CT or MRI
performed at screening and every 6 weeks
Drug: Docetaxel
60mg/m2 intravenous infusion
Other Name: Paxel
Experimental: Gefitinib
Gefitinib (IRESSA)
Drug: Gefitinib
250 mg oral
Other Name: IRESSA
Procedure: CT or MRI
performed at screening and every 6 weeks

Primary Outcome Measures :
  1. Number of Patients With Adverse Event (AE) [ Time Frame: From time consent was given to 28 days after last dose of study drug. ]
  2. Number of Patients With Serious Adverse Events (SAEs) [ Time Frame: From time consent was given to 28 days after last dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC, not amenable to curative surgery or radiotherapy
  • Treatment with one prior chemotherapy regimen, which must have been platinum based* *Patients must have demonstrated radiological or clinical progression since completion of previous chemotherapy regimen.
  • Adequate hepatic function, defined as BOTH a bilirubin < upper limit of reference range (ULRR) AND an "Eligible" combination of transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) and alkaline phosphatase (ALP) below: Not Eligible: AST or ALT > 5xULRR, 1.5xULRR < AST or ALT < 5xULRR and ALP> ULRR, 1xULRR < AST or ALT < 1.5xULRR and ALP> 2.5xULRR, AST or ALT <= ULRR and ALP> 5xULRR For more information please refer to TAXOTERE® (docetaxel) prescribing information

Exclusion Criteria:

  • Prior therapy with gefitinib or other EGFR TK inhibitors (HER-1 receptor inhibitors/small molecule or monoclonal antibody therapy)

    • Prior docetaxel treatment for NSCLC
    • Patients with pre-existing peripheral neuropathy ³ grade 2 (NCI CTCAE criteria)
    • Past medical history of interstitial lung disease, drug induced interstitial disease, radiation pneumonitis that required steroid treatment or any evidence of clinically active interstitial lung disease

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): NCT00536107

Research Site
Taipei, Taiwan
Sponsors and Collaborators
Principal Investigator: Han-Pin Kuo, MD Director of Chest Department, Chang Gung Memorial Hospital, Linkou

Responsible Party: AstraZeneca Identifier: NCT00536107     History of Changes
Other Study ID Numbers: D7913C00046
First Posted: September 27, 2007    Key Record Dates
Results First Posted: October 1, 2013
Last Update Posted: October 1, 2013
Last Verified: August 2013

Keywords provided by AstraZeneca:
Non-Small Cell Lung Cancer
Locally Advanced or Metastatic NSCL Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors