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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193453
First received: September 12, 2005
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Lung Cancer
Drug: Gemcitabine
Drug: Docetaxel
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 69
Study Start Date: July 2005
Study Completion Date: December 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Upon determination of eligibility all patients will receive:

  • Docetaxel + Gemcitabine + Cetuximab
  Eligibility

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

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193453

Locations
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
Investigators
Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193453     History of Changes
Other Study ID Numbers: SCRI LUN 92
Study First Received: September 12, 2005
Results First Received: October 11, 2012
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Lung Cancer

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

ClinicalTrials.gov processed this record on October 23, 2014