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Completed

NCT Number: NCT00193453

Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced 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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northeast Alabama Regional Medical Center, Anniston, Alabama, United States

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About this study

Upon determination of eligibility all patients will receive:

  • Docetaxel + Gemcitabine + Cetuximab

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

1000mg/m2 30min IV, Day 1 & 8

Other names: Gemzar

docetaxel

Drug

30mg/m2, 30min IV, day 1 & 8

Other names: Taxotere

Cetuximab

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Nov 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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