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Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

NCT ID: NCT00112294

Last Updated: 2015-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

755 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small-Cell Lung Carcinoma

Keywords

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cetuximab+Taxane+Carboplatin (C/T/C)

Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Group Type ACTIVE_COMPARATOR

Paclitaxel (Taxane)

Intervention Type DRUG

IV, 225 mg/m\^2

Docetaxel (Taxane)

Intervention Type DRUG

IV, 75 mg/m\^2

Carboplatin

Intervention Type DRUG

AUC=6, q 3 weeks (6 cycles maximum)

Cetuximab

Intervention Type DRUG

Intravenous, 400 mg/m\^2, initial dose followed by 250 mg/m\^2, weekly starting on Week 2

Taxane+Carboplatin (T/C)

A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Group Type ACTIVE_COMPARATOR

Paclitaxel (Taxane)

Intervention Type DRUG

IV, 225 mg/m\^2

Docetaxel (Taxane)

Intervention Type DRUG

IV, 75 mg/m\^2

Carboplatin

Intervention Type DRUG

AUC=6, q 3 weeks (6 cycles maximum)

Interventions

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Paclitaxel (Taxane)

IV, 225 mg/m\^2

Intervention Type DRUG

Docetaxel (Taxane)

IV, 75 mg/m\^2

Intervention Type DRUG

Carboplatin

AUC=6, q 3 weeks (6 cycles maximum)

Intervention Type DRUG

Cetuximab

Intravenous, 400 mg/m\^2, initial dose followed by 250 mg/m\^2, weekly starting on Week 2

Intervention Type DRUG

Other Intervention Names

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Erbitux

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Anchorage, Alaska, United States

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Tucson, Arizona, United States

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Springdale, Arkansas, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Concord, California, United States

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Fountain Valley, California, United States

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Gilroy, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Montebello, California, United States

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Oxnard, California, United States

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Rancho Mirage, California, United States

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San Diego, California, United States

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Stockton, California, United States

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Vista, California, United States

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Lakewood, Colorado, United States

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Binghamton, Connecticut, United States

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Hartford, Connecticut, United States

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New London, Connecticut, United States

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Norwich, Connecticut, United States

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Stamford, Connecticut, United States

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Waterbury, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Inverness, Florida, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Lecanto, Florida, United States

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Pembroke Pines, Florida, United States

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Port Saint Lucie, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Columbus, Georgia, United States

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Marietta, Georgia, United States

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Honolulu, Hawaii, United States

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Evanston, Illinois, United States

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Joliet, Illinois, United States

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Naperville, Illinois, United States

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Normal, Illinois, United States

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Skokie, Illinois, United States

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Fort Wayne, Indiana, United States

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Muncie, Indiana, United States

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New Albany, Indiana, United States

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Terre Haute, Indiana, United States

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Vincennes, Indiana, United States

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Wichita, Kansas, United States

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Hazard, Kentucky, United States

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Paducah, Kentucky, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Westminster, Maryland, United States

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Boston, Massachusetts, United States

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Brockton, Massachusetts, United States

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Flint, Michigan, United States

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Free Soil, Michigan, United States

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Grand Rapids, Michigan, United States

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Jackson, Michigan, United States

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Dulluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Jackson, Mississippi, United States

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Columbia, Missouri, United States

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Jefferson City, Missouri, United States

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Dover, New Hampshire, United States

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Newark, New Jersey, United States

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Cooperstown, New York, United States

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New City, New York, United States

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New Rochelle, New York, United States

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Northport, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Gastonia, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Hickory, North Carolina, United States

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Morganton, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bethlehem, Pennsylvania, United States

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Dunmore, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pottstown, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Spartanburg, South Carolina, United States

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Sumter, South Carolina, United States

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Chattanooga, Tennessee, United States

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Collierville, Tennessee, United States

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Cookeville, Tennessee, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Danville, Virginia, United States

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Lynchburg, Virginia, United States

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Richmond, Virginia, United States

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Everett, Washington, United States

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Lacey, Washington, United States

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Tacoma, Washington, United States

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Huntington, West Virginia, United States

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La Crosse, Wisconsin, United States

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Madison, Wisconsin, United States

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Countries

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Canada United States

Other Identifiers

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CA225-099

Identifier Type: -

Identifier Source: org_study_id