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Cetuximab, Gemcitabine, and Carboplatin in Treating Patients With Stage IV Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027755
  Purpose

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy and chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining monoclonal antibody therapy with chemotherapy in treating patients who have stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: cetuximab
Drug: gemcitabine hydrochloride
Phase I
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Carboplatin    Gemcitabine hydrochloride    Gemcitabine    Cetuximab    Epidermal Growth Factor   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFR) Antibody, Cetuximab, in Combination With Cemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 2001

Detailed Description:

OBJECTIVES: I. Determine the safety and toxicity of cetuximab when administered in combination with gemcitabine and carboplatin in patients with chemotherapy-naive stage IV non-small cell lung cancer. II. Determine the response rate and time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15, and gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience unacceptable toxicity to gemcitabine or carboplatin may continue to receive cetuximab alone. Patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 5-7 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer that is not amenable to potentially curative surgery Stage IV Epidermal growth factor receptor expression (1+ or more) by immunohistochemistry Measurable disease Chemotherapy-naive Histologically confirmed recurrent disease allowed after radiotherapy Meningeal or CNS involvement allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled angina No arrhythmias No congestive heart failure Neurologic: No uncontrolled seizure disorder No active neurological disease No neuropathy of grade 2 or greater Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior cetuximab Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior wide-field radiotherapy (local radiotherapy for management of tumor-related symptoms allowed) No concurrent radiotherapy Surgery: See Disease Characteristics At least 30 days since prior major thoracic or abdominal surgery and recovered Other: At least 30 days since prior investigational agents At least 4 weeks since any prior therapy and recovered

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027755

Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center    
      Birmingham, Alabama, United States, 35294-3300

Sponsors and Collaborators
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
National Cancer Institute (NCI)

Investigators
Study Chair:     Francisco Robert, MD, FACP     Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000069063, UAB-9909, IMCL-CP02-9925, UAB-F010524006, NCI-G01-2030
First Received:   December 7, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00027755
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer  
stage IV non-small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Cetuximab
Carboplatin
Recurrence
Carcinoma
Antibodies
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on December 03, 2008




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