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Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

This study has been completed.
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC Identifier:
First received: September 12, 2005
Last updated: October 11, 2012
Last verified: October 2012

September 12, 2005
October 11, 2012
July 2005
February 2009   (final data collection date for primary outcome measure)
Overall Clinical Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Overall response rate was defined as the proportion of treated patients whose best response was a complete or partial response after completing at least two courses of treatment.
Overall Clinical Response Rate
Complete list of historical versions of study NCT00193453 on Archive Site
  • Progression Free Survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause.
  • Response Duration [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
  • Progression free survival
  • Toxicity of drug combination
Not Provided
Not Provided
Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer
A Phase II Trial of First-Line Therapy With Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Stage III or IV Non-Small Cell Lung Cancer
This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Upon determination of eligibility all patients will receive:

  • Docetaxel + Gemcitabine + Cetuximab
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: Gemcitabine
    1000mg/m2 30min IV, Day 1 & 8
    Other Name: Gemzar
  • Drug: Docetaxel
    30mg/m2, 30min IV, day 1 & 8
    Other Name: Taxotere
  • Drug: Cetuximab
    100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 & 15, all subsequent cycles 250mg/m2 IV day 1, 8, & 15
    Other Name: Erbitux
Experimental: Intervention
Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
  • Drug: Gemcitabine
  • Drug: Docetaxel
  • Drug: Cetuximab
Spigel DR, Greco FA, Thompson DS, Webb C, Rubinsak J, Inhorn RC, Reeves J Jr, Vazquez ER, Lane CM, Burris HA 3rd, Hainsworth JD. Phase II study of cetuximab, docetaxel, and gemcitabine in patients with previously untreated advanced non-small-cell lung cancer. Clin Lung Cancer. 2010 May;11(3):198-203. doi: 10.3816/CLC.2010.n.026.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

To be included in the study, you must meet the following criteria:

  • 18 years of age or older
  • Non-small cell lung cancer confirmed by biopsy
  • Unresectable stage III or IV disease
  • Measurable disease
  • Must not have received any prior chemotherapy for lung cancer
  • Able to perform activities of daily living without considerable assistance
  • Adequate bone marrow, kidney, and liver function
  • Signed informed consent

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

  • History of serious heart disease within six months prior to study entry
  • Prior treatment with agents that target the EGFR pathway
  • History of any other uncontrolled or significant disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
Bristol-Myers Squibb
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP