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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 Institution Chicago, Illinois  
Local Institution Indianapolis, Indiana  
Local Institution Baltimore, Maryland  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Vancouver, Washington  
Local Institution Green Bay, Wisconsin  
Local Institution Birmingham, Alabama  
Local Institution Phoenix, Arizona  
Local Institution Corona, California  
Local Institution Aurora, Colorado  
Local Institution Hamden, Connecticut  
Local Institution Washington, District of Columbia  
Local Institution Fort Lauderdale, Florida  
Local Institution Wichita, Kansas  
Local Institution Springfield, Massachusetts  
Local Institution Duluth, Minnesota  
Local Institution New Brunswick, New Jersey  
Local Institution Wilmington, North Carolina  
Local Institution Oklahoma City, Oklahoma  
Local Institution Duncansville, Pennsylvania  
Local Institution North Charleston, South Carolina  
Local Institution Austin, Texas  
Local Institution Arlington, Virginia  
Local Institution Rome, Georgia  
Local Institution Bismarck, North Dakota  
Local Institution Providence, Rhode Island  
Local Institution Chattanooga, Tennessee  
Local Institution Little Rock, Arkansas  
Local Institution Jackson, Mississippi  
Local Institution Columbia, Missouri  
Local Institution Morgantown, West Virginia  
Local Institution Louisville, Kentucky  
Local Institution Detroit, Michigan  
Local Institution Honolulu, Hawaii  
Local Institution Lebanon, New Hampshire  
Local Institution Anchorage, Alaska