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


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma

Thank you

Trial Information

A Randomized Multicenter Phase III Study of Taxane/Carboplatin/Cetuximab Versus Taxane/Carboplatin 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.

- Tumor/disease lesions that can be measured bidimensionally.

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

- Adequate recovery from recent surgery or radiation therapy.

- Must be at least 4 weeks from last major surgery or prior treatment with an
investigational agent. At least 12 weeks from any radiation therapy to chest.

- Accessible for treatment, follow-up and required visits at a participating center(s).

Exclusion Criteria:

- Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.

- Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted
therapy.

- Prior severe infusion reaction to antibody therapy.

- Concurrent malignancy (previous malignancy without evidence of disease for 5 years
will be allowed to enter trial).

- Concurrent chemotherapy or therapy with another investigational agent not indicated
in the protocol.

- Serious uncontrolled medical disorders that would impair the ability to receive
therapy.

- History of myocardial infarction within prior 3 months, uncontrolled angina,
uncontrolled arrhythmia, or uncontrolled congestive heart failure.

- Symptomatic or uncontrolled metastases in the central nervous system. Subjects
receiving a glucocorticoid for central nervous system (CNS) metastases are not
eligible, but those receiving an anticonvulsant are eligible.

- Peripheral neuropathy >= grade 2 (Common Toxicity Criteria Adverse Event [CTCAE]
Version 3.0).

- Inadequate hematologic and/or liver and/or kidney function.

- Sexually active and fertile individuals or partners of these individuals who are
unwilling or unable to use an acceptable method of birth control for entire trial and
up to 4 weeks after the study.

- Women who are pregnant or breastfeeding.

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

- Altered mental status or psychiatric condition that prohibits understanding or
rendering of consent.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Median Number of Months of Progression-free Survival (PFS)

Outcome Description:

Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.

Outcome Time Frame:

From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA225-099

NCT ID:

NCT00112294

Start Date:

December 2004

Completion Date:

August 2008

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Non-Small Cell 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 InstitutionVancouver, Washington  
Local InstitutionGreen Bay, Wisconsin  
Local InstitutionBirmingham, Alabama  
Local InstitutionPhoenix, Arizona  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionHamden, Connecticut  
Local InstitutionWashington, District of Columbia  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionDuluth, Minnesota  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionWilmington, North Carolina  
Local InstitutionOklahoma City, Oklahoma  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Local InstitutionArlington, Virginia  
Local InstitutionRome, Georgia  
Local InstitutionBismarck, North Dakota  
Local InstitutionProvidence, Rhode Island  
Local InstitutionChattanooga, Tennessee  
Local InstitutionLittle Rock, Arkansas  
Local InstitutionJackson, Mississippi  
Local InstitutionColumbia, Missouri  
Local InstitutionMorgantown, West Virginia  
Local InstitutionLouisville, Kentucky  
Local InstitutionDetroit, Michigan  
Local InstitutionHonolulu, Hawaii  
Local InstitutionLebanon, New Hampshire  
Local InstitutionAnchorage, Alaska