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Trial record 31 of 45 for:    colon cancer | ( Map: Hawaii, United States )

Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal 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: NCT00063141
Recruitment Status : Completed
First Posted : June 25, 2003
Last Update Posted : April 12, 2010
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC

Tracking Information
First Submitted Date  ICMJE June 20, 2003
First Posted Date  ICMJE June 25, 2003
Last Update Posted Date April 12, 2010
Study Start Date  ICMJE April 2003
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2008)
Overall Survival [ Time Frame: Every 3 months after subject off-treatment ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00063141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2008)
  • Progression Free Survival [ Time Frame: Q6 Weeks ]
  • Response [ Time Frame: Q6 Weeks ]
  • Duration of Response [ Time Frame: Q6 Weeks ]
  • Time to Response [ Time Frame: Q6 Weeks ]
  • Disease Control Rate [ Time Frame: Q6 Weeks ]
  • Safety [ Time Frame: Q3 Weeks ]
  • Quality of Life [ Time Frame: Q6 Weeks ]
  • Health Economics [ Time Frame: Q3 Weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
Official Title  ICMJE Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma
Brief Summary The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: cetuximab
    Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
    Other Name: Erbitux
  • Drug: Irinotecan
    Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Study Arms  ICMJE
  • Experimental: Arm A
    Interventions:
    • Drug: cetuximab
    • Drug: Irinotecan
  • Active Comparator: Arm B
    Intervention: Drug: Irinotecan
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 27, 2008)
1302
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
1300
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry [IHC] (may be based on archival samples) and is metastatic.
  • Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.
  • Prior fluoropyrimidine-containing regimen (5-fluorouracil [5-FU], capecitabine, or uracil/tegafur [UFT]), for the first-line treatment of metastatic disease.

Exclusion Criteria:

  • A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy
  • Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease
  • Known or documented brain metastases
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,   Australia,   Austria,   Belgium,   Czech Republic,   Finland,   France,   Germany,   Hong Kong,   Italy,   Netherlands,   Norway,   Portugal,   Slovakia,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00063141
Other Study ID Numbers  ICMJE CA225-006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, ImClone Systems
Study Sponsor  ICMJE ImClone LLC
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
PRS Account ImClone LLC
Verification Date April 2010

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