Clinical trial NCT00112294: Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Non-Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-06-02
Enrollment: 755
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.


Eligibility criteria: 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.

Primary outcomes:
measure: Median Number of Months of Progression-free Survival (PFS)
timeFrame: From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).
Secondary outcomes:
measure: Number of Participants With Complete Response (CR) or Partial Response (PR)
timeFrame: From randomization to end of study drug therapy (up to 174 weeks).
measure: Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
timeFrame: From randomization to end of study drug therapy (up to 174 weeks).
measure: Median Number of Months of Response
timeFrame: Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).
measure: Median Number of Months to Response
timeFrame: Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).
measure: Median Number of Months of Survival
timeFrame: From randomization to death or date of last contact (up to 41 months).
measure: Number of Participants With Improvement of Symptoms
timeFrame: From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).
measure: Median Number of Months Until Symptomatic Progression (Worsening of Symptoms)
timeFrame: From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).
measure: Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)
timeFrame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).
measure: Number of Participants Experiencing AEs Leading to Study Drug Discontinuation
timeFrame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).
measure: Number of Participants Experiencing Other Significant AEs: Acneform Rash
timeFrame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).
measure: Number of Participants Experiencing Other Significant AEs: Infusion Reaction
timeFrame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).
measure: Number of Participants Experiencing Other Significant AEs: Cardiac AEs
timeFrame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).
measure: Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants
timeFrame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).
measure: Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants
timeFrame: From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).
measure: Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures
timeFrame: Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation).
Other outcomes:
measure: Median Change From Baseline in Symptoms, by Time Point
timeFrame: From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).
Locations:
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Mobile
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state: Alabama
city: Anchorage
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state: California
city: Long Beach
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city: Los Angeles
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state: Connecticut
city: New London
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state: Connecticut
city: Norwich
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city: Stamford
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state: Connecticut
city: Waterbury
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state: Connecticut
city: Washington
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state: District of Columbia
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city: Lecanto
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city: Pembroke Pines
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state: Florida
city: Port Saint Lucie
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state: Florida
city: Tamarac
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state: Florida
city: Tampa
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state: Florida
city: Augusta
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state: Georgia
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city: Marietta
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state: Georgia
city: Honolulu
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city: Joliet
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city: Normal
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city: Westminster
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city: Boston
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city: Brockton
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city: Flint
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city: Free Soil
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city: Grand Rapids
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state: Michigan
city: Jackson
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state: Michigan
city: Dulluth
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state: Minnesota
city: Minneapolis
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city: St. Louis Park
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state: Minnesota
city: Jackson
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state: Mississippi
city: Columbia
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state: Missouri
city: Jefferson City
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state: Missouri
city: Dover
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state: New Hampshire
city: Newark
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state: New Jersey
city: Bronx
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state: New York
city: Cooperstown
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state: New York
city: New City
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state: New York
city: New Rochelle
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state: New York
city: Northport
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state: New York
city: Rochester
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state: New York
city: Valhalla
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facility: Local Institution
state: New York
city: Burlington
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facility: Local Institution
state: North Carolina
city: Charlotte
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facility: Local Institution
state: North Carolina
city: Gastonia
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facility: Local Institution
state: North Carolina
city: Greensboro
country: United States
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state: North Carolina
city: Greenville
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facility: Local Institution
state: North Carolina
city: Hickory
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state: North Carolina
city: Morganton
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state: North Carolina
city: Wilmington
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facility: Local Institution
state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Bismarck
country: United States
facility: Local Institution
state: North Dakota
city: Bismark
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state: North Dakota
city: Canton
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state: Ohio
city: Cincinnati
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state: Ohio
city: Cleveland
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Dayton
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state: Ohio
city: Oklahoma City
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state: Oklahoma
city: Bethlehem
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state: Pennsylvania
city: Dunmore
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state: Pennsylvania
city: Harrisburg
country: United States
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Pottstown
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state: Pennsylvania
city: Sayre
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state: Pennsylvania
city: West Reading
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state: Pennsylvania
city: Providence
country: United States
facility: Local Institution
state: Rhode Island
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Local Institution
state: South Carolina
city: Spartanburg
country: United States
facility: Local Institution
state: South Carolina
city: Sumter
country: United States
facility: Local Institution
state: South Carolina
city: Chattanooga
country: United States
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state: Tennessee
city: Collierville
country: United States
facility: Local Institution
state: Tennessee
city: Cookeville
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state: Tennessee
city: Amarillo
country: United States
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state: Texas
city: Dallas
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state: Texas
city: Houston
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state: Texas
city: Lubbock
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state: Texas
city: Danville
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state: Virginia
city: Lynchburg
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city: Richmond
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state: Virginia
city: Everett
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city: Lacey
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state: Washington
city: Tacoma
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state: Washington
city: Huntington
country: United States
facility: Local Institution
state: West Virginia
city: La Crosse
country: United States
facility: Local Institution
state: Wisconsin
city: Madison
country: United States
facility: Local Institution
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: