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Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced 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: NCT00193453
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 13, 2012
Last Update Posted : November 13, 2012
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Gemcitabine Drug: Docetaxel Drug: Cetuximab Phase 2

Detailed Description:

Upon determination of eligibility all patients will receive:

  • Docetaxel + Gemcitabine + Cetuximab

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. Overall Clinical Response Rate [ Time Frame: 18 months ]
    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.

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 18 months ]
    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.

  2. Response Duration [ Time Frame: 18 months ]
    The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.

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

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.

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): NCT00193453

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United States, Alabama
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
United States, Arkansas
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Gainsville Hematology Oncology Associates
Gainesville, Florida, United States, 32605
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Kentucky
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Maine
Mercy Hospital
Portland, Maine, United States, 04101
United States, Pennsylvania
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, United States, 19026
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Bristol-Myers Squibb
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Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results:
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Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00193453     History of Changes
Other Study ID Numbers: SCRI LUN 92
First Posted: September 19, 2005    Key Record Dates
Results First Posted: November 13, 2012
Last Update Posted: November 13, 2012
Last Verified: October 2012

Keywords provided by SCRI Development Innovations, LLC:
Lung Cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Immunological