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

October 11, 2012 updated by: SCRI Development Innovations, LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upon determination of eligibility all patients will receive:

  • Docetaxel + Gemcitabine + Cetuximab

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Northeast Alabama Regional Medical Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Northeast Arkansas Clinic
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Gainesville, Florida, United States, 32605
        • Gainsville Hematology Oncology Associates
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
      • Louisville, Kentucky, United States, 40207
        • Consultants in Blood Disorders and Cancer
    • Maine
      • Portland, Maine, United States, 04101
        • Mercy Hospital
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States, 19026
        • Consultants in Medical Oncology and Hematology
    • Tennessee
      • Nashville, Tennessee, United States, 37023
        • Tennessee Oncology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Gemzar
Drug: Docetaxel
30mg/m2, 30min IV, day 1 & 8
Other Names:
  • 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 Names:
  • Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

November 13, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI LUN 92

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on Gemcitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe