Know Cancer

or
forgot password

A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma

Thank you

Trial Information

A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer


Inclusion Criteria:



- Must have advanced or metastatic non-small cell lung cancer that has not been
previously treated with any chemotherapy.

- Must not have received cetuximab or any medications that target the same pathway as
cetuximab (such as Iressa or Tarceva).

- Must not have had hypersensitivity or severe allergic reactions to any monoclonal
antibodies and must not have severe restrictive or interstitial lung disease.

- Must be able to carry out work of light or sedentary nature (e.g. light house work,
office work).

- It must be at least 4 weeks since last major surgery or prior treatment with an
investigational product and at least 12 weeks from any radiation therapy to the
chest.

Exclusion Criteria:

- Women who are pregnant or breastfeeding.

- Women with a positive pregnancy test on enrollment or prior to study drug
administration.

- Any concurrent malignancy (subjects with a previous malignancy but without evidence
of disease for 5 years will be allowed to enter the trial).

- Symptomatic or uncontrolled metastases in the central nervous system (CNS).

- Peripheral neuropathy.

- Inadequate hematologic function defined by an absolute neutrophil count (ANC)
<1,500/mm^3, a platelet count <100,000/mm^3, or a hemoglobin level < 9g/dL.

- Inadequate liver function.

- Inadequate kidney function.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tumor response per treatment arm

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA225-100

NCT ID:

NCT00112346

Start Date:

January 2005

Completion Date:

December 2006

Related Keywords:

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

Name

Location

Local InstitutionChicago, Illinois  
Local InstitutionIndianapolis, Indiana  
Local InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionPortland, Oregon  
Local InstitutionVancouver, Washington  
Local InstitutionBirmingham, Alabama  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionAlbuquerque, New Mexico  
Local InstitutionWilmington, North Carolina  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Local InstitutionRome, Georgia  
Local InstitutionBismarck, North Dakota  
Local InstitutionHonolulu, Hawaii  
Local InstitutionAnchorage, Alaska