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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00112346
Recruitment Status : Completed
First Posted : June 2, 2005
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The primary purpose of this study is to estimate the number of patients with non-small cell lung cancer whose tumor responds to the treatments given in this study.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: Cetuximab + platinum + gemcitabine Drug: Platinum + Gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A Drug: Cetuximab + platinum + gemcitabine
Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.
Other Name: Erbitux

Active Comparator: B Drug: Platinum + Gemcitabine
Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 & Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.




Primary Outcome Measures :
  1. tumor response per treatment arm

Secondary Outcome Measures :
  1. disease control, symptom response, symptomatic progression, & progression free survival.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112346


Locations
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United States, Alabama
Local Institution
Mobile, Alabama, United States
United States, Alaska
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Anchorage, Alaska, United States
United States, California
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Bakersfield, California, United States
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Corona, California, United States
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Oxnard, California, United States
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San Diego, California, United States
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Whittier, California, United States
United States, Colorado
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Lakewood, Colorado, United States
United States, Florida
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Boynton Beach, Florida, United States
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Brooksville, Florida, United States
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Inverness, Florida, United States
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Pembroke Pines, Florida, United States
United States, Georgia
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Austell, Georgia, United States
United States, Hawaii
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Honolulu, Hawaii, United States
United States, Illinois
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Skokie, Illinois, United States
United States, Indiana
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Muncie, Indiana, United States
United States, Maryland
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Annapolis, Maryland, United States
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Frederick, Maryland, United States
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Rockville, Maryland, United States
United States, Massachusetts
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Plymouth, Massachusetts, United States
United States, New Mexico
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Farmington, New Mexico, United States
United States, New York
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Armonk, New York, United States
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Stony Brook, New York, United States
United States, North Carolina
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Gastonia, North Carolina, United States
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Wilmington, North Carolina, United States
United States, North Dakota
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Bismarck, North Dakota, United States
United States, Ohio
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Cincinnati, Ohio, United States
United States, Oregon
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Portland, Oregon, United States
United States, South Carolina
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Charleston, South Carolina, United States
United States, Texas
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Dallas, Texas, United States
United States, Washington
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Vancouver, Washington, United States
Canada, Alberta
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Edmonton, Alberta, Canada
Canada, New Brunswick
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Moncton, New Brunswick, Canada
Canada, Ontario
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Hamilton, Ontario, Canada
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Montreal, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
Canada, Quebec
Local Institution
Greenfield Park, Quebec, Canada
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00112346    
Other Study ID Numbers: CA225-100
First Posted: June 2, 2005    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Eli Lilly and Company:
Non-Small Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological