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Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer

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ClinicalTrials.gov Identifier: NCT01004731
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : June 28, 2010
Sponsor:
Collaborator:
ImClone LLC
Information provided by:
University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE October 21, 2009
First Posted Date  ICMJE October 30, 2009
Last Update Posted Date June 28, 2010
Study Start Date  ICMJE June 2001
Actual Primary Completion Date January 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Evaluate the tumor response of cetuximab in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, Stage IV non-small cell lung cancer. [ Time Frame: 3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01004731 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Evaluate the response rate and time to disease progression [ Time Frame: 3-week cycles with evaluation after every 2 cycles until disease progression or unacceptable toxicity ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer
Official Title  ICMJE Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer
Brief Summary The objective is to evaluate the toxicity profile, response rate, and time to progression of Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with advanced non-small cell lung cancer with positive EGFr expression.
Detailed Description

The primary objective of this study is to evaluate the safety profile of Cetuximab when used in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC).

Also, the study will determine the response rate in patients with EGFr positive chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC) treated with Cetuximab in combination with gemcitabine and carboplatin as well as determine the time to progression in patients with EGFr positive chemotherapy-naive, stage IV NSCLC treated with Cetuximab in combination with gemcitabine and carboplatin.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stage IV Non-small Cell Lung Cancer
Intervention  ICMJE Drug: Cetuximab in combination with Carboplatin/Gemcitabine
A loading dose of Cetuximab (400 mg/m2 IV over 120 minutes) will be administered 1 week prior to chemotherapy. Thereafter, Cetuximab will be infused weekly at maintenance doses of 250 mg/m2 (over 60 minutes). On the first day of each new cycle of therapy, Carboplatin will be infused with Gemcitabine (Days 1 and 8). Patients will be evaluated for a tumor response following every two cycles of therapy. In the absence of progressive disease, patients may continue to receive additional therapy.
Study Arms  ICMJE Experimental: Cetuximab in combination with Carboplatin/Gemcitabine
Approximately 30 patients with advanced NSCLC will be enrolled. Patients will receive 3-week cycles of Cetuximab in combination with Carboplatin/Gemcitabine.
Intervention: Drug: Cetuximab in combination with Carboplatin/Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2009)
7
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2006
Actual Primary Completion Date January 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of histologically/cytologically confirmed advanced non- small cell lung cancer (NSCLC).
  • Have uni-dimensionally measurable and/or evaluable advanced NSCLC.
  • Have Stage IV or recurrent disease following radiation therapy.
  • Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at study entry.
  • Have given signed informed consent.
  • Be at least 18 years of age.
  • Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or equal to 9 g/dL.
  • Have total bilirubin less than or equal to 1.5 x upper limits of normal, Alk Phos, AST and ALT less than or equal to 2.5 x upper limits of normal.
  • Have serum creatinine less than or equal to 1.5 mg/dL, or calculated creatinine clearance greater than or equal to 60 cc/minute.
  • Be disease free from a previously treated malignancy for more than three years. Patients with a history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded.
  • Agree to use effective contraception if procreative potential exists.
  • Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.

Exclusion Criteria:

  • Have received prior murine monoclonal antibody or Cetuximab therapy.
  • Have disease amenable to curative surgery.
  • Have received prior chemotherapy.
  • Have received radiation therapy within 3 weeks prior to the first infusion of Cetuximab.
  • Have a history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities, in the judgment of the PI.
  • Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher neuropathy.
  • Be pregnant or breast-feeding.
  • Have received any investigational agent(s) within 1 month of study entry.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004731
Other Study ID Numbers  ICMJE X010524006
UAB 9909 ( Other Identifier: UAB Department study number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francisco Robert, M.D., University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE ImClone LLC
Investigators  ICMJE
Principal Investigator: Francisco Robert, M.D. University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP