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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Every 3 months after subject off-treatment

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Chair

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

CA225-006

NCT ID:

NCT00063141

Start Date:

April 2003

Completion Date:

October 2007

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

ImClone Investigational SiteDenver, Colorado  80262
ImClone Investigational SiteGreenwich, Connecticut  06830
ImClone Investigational SiteIndianapolis, Indiana  46202
ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteSt. Charles, Missouri  63301
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteAtlanta, Georgia  30318
ImClone Investigational SiteDecatur, Illinois  62526
ImClone Investigational SiteLouisville, Kentucky  40202
ImClone Investigational SiteNew Orleans, Louisiana  70121
ImClone Investigational SiteBaltimore, Maryland  21204
ImClone Investigational SiteYpsilanti, Michigan  48198
ImClone Investigational SiteMinneapolis, Minnesota  55416
ImClone Investigational SiteVoorhees, New Jersey  08043
ImClone Investigational SiteCleveland, Ohio  44134
ImClone Investigational SiteGreenville, South Carolina  29605
ImClone Investigational SiteMemphis, Tennessee  38104
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SiteNorfolk, Virginia  23502
ImClone Investigational SiteGreen Bay, Wisconsin  54307
ImClone Investigational SiteLittle Rock, Arkansas  72205
ImClone Investigational SiteWinston-Salem, North Carolina  27103
ImClone Investigational SiteBismarck, North Dakota  58501
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteOgden, Utah  84403
ImClone Investigational SiteTucson, Arizona  85712
ImClone Investigational SiteHonolulu, Hawaii  96813
ImClone Investigational SiteKansas City, Kansas  66160
ImClone Investigational SiteBoston, Massachusetts  02135
ImClone Investigational SiteJackson, Mississippi  39202
ImClone Investigational SiteOklahoma City, Oklahoma  73118
ImClone Investigational SiteSeattle, Washington  98104