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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


Upon determination of eligibility all patients will receive:

- Docetaxel + Gemcitabine + Cetuximab


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Clinical Response Rate

Outcome Description:

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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 92

NCT ID:

NCT00193453

Start Date:

July 2005

Completion Date:

December 2009

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Northeast Arkansas ClinicJonesboro, Arkansas  72401-3125
Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
Mercy HospitalPortland, Maine  04101
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Gainsville Hematology Oncology AssociatesGainesville, Florida  32605
Graves-Gilbert ClinicBowling Green, Kentucky  42101
Consultants in Medical Oncology and HematologyDrexel Hill, Pennsylvania  19026