Cetuximab, Capecitabine and Oxaliplatin in Patients With Epidermal Growth Factor Receptor (EGFr) Expressing Metastatic 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. Identifier: NCT00444678
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : February 27, 2018
ImClone LLC
Bristol-Myers Squibb
Information provided by (Responsible Party):
New York University School of Medicine

March 7, 2007
March 8, 2007
February 27, 2018
June 1, 2004
August 1, 2012   (Final data collection date for primary outcome measure)
Response rate for the combination treatment [ Time Frame: 6 months since the start of treatment ]
Response rate for the combination treatment
Complete list of historical versions of study NCT00444678 on Archive Site
  • Toxicity rates [ Time Frame: 1 year since the first treatment and every year after ]
  • Time to progression [ Time Frame: 6 months since the start of treatment and every 3 months after treatment ]
  • Survival [ Time Frame: 6 months since the start of treatment and every 3 months after treatment ]
  • Toxicity rates
  • Time to progression
  • Survival
Not Provided
Not Provided
Cetuximab, Capecitabine and Oxaliplatin in Patients With Epidermal Growth Factor Receptor (EGFr) Expressing Metastatic Colorectal Cancer
A Phase II Study of Cetuximab Plus Biweekly Capecitabine and Oxaliplatin (C-CO2) in the Treatment of Patients With EGFR-Expressing Metastatic Colorectal Cancer
This trial will examine the addition of Cetuximab in combination with Oxaliplatin and Capecitabine for treatment of patients with previously untreated metastatic colorectal cancer.
The current treatment options for metastatic colon cancer are in need of further improvement. The three-drug combination of oxaliplatin with 5-FU/LV in the second-line treatment of metastatic colorectal cancer have shown a significant increase in response rate compared to 5-FU/LV alone. Oxaliplatin has recently been FDA-approved for this indication and is now a standard first-line agent in combination with a fluoropyrimidine. Cetuximab, a chimeric monoclonal antibody against the growth factor receptor, has shown activity with and without irinotecan in subjects with colorectal cancer refractory to irinotecan alone. Cetuximab has also been shown to be safe and effective when administered with infusional 5-FU/folinic acid plus irinotecan. These results suggest that the addition of cetuximab to fluoropyrimidine/oxaliplatin-based regimen in the 1st line setting should be explored. The use of the oral fluoropyrimidine, capecitabine, to replace infusional 5FU has been widely used for improved convenience and possible safety. We have chosen a modified biweekly CapeOx regimen due to its improved tolerance and response rate with a fixed dose of capecitabine given its widespread practice and ease of use.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colorectal Cancer
  • Neoplasm Metastasis
  • Drug: Cetuximab
    500 mg/m2, IV every two weeks
    Other Names:
    • Erbitux
    • C225
  • Drug: Oxaliplatin
    85 mg/m2, IV, q 2 weeks
    Other Name: Eloxatin
  • Drug: Capecitabine
    2500 mg, po bid x 7 days every two weeks
    Other Name: Xeloda
Experimental: Cetuximab, Capecitabine and Oxaliplatin
  • Drug: Cetuximab
  • Drug: Oxaliplatin
  • Drug: Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 1, 2015
August 1, 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have signed an approved informed consent.
  • Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum, with KRAS wild type on mutational analysis.
  • No prior chemotherapy for metastatic disease (chemotherapy naive). Prior adjuvant therapy with 5FU/LV or IFL is permitted if completed at least six months prior to entering this study.
  • Measurable disease by RECIST criteria as defined in Section 3.3.1.
  • Subjects for whom tumor tissue is available for IHC testing for EGFR expression.
  • ECOG Performance Status 0-1.
  • Recovery in full from any previous surgical procedure.
  • Expected survival greater than 12 weeks.
  • Subjects at least 18 years of age.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
  • Adequate hematologic function defined by an absolute neutrophil count (ANC) > 1,500/mm3, a platelet count > 100,000/mm3 .
  • Adequate hepatic function defined by a total bilirubin level no greater than 2.0 times the upper limit of normal (ULN) and AST and ALT levels noo greater than 2.5 times the ULN (AST and ALT levels no greater than 5 times the ULN in the presence of liver metastases).
  • Adequate renal function defined by a serum creatinine level no greater than 1.5 times the ULN.

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential.
  • Subjects with > Grade 1 neuropathy.
  • Any active or uncontrolled infection.
  • History of myocardial infarction within the previous six months or current clinical evidence of congestive heart failure.
  • History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
  • Central nervous system metastases.
  • Pregnant or lactating women. Men and women of reproductive potential must agree to use an effective contraceptive method.
  • Medical or psychiatric disorders that would interfere with informed consent or make them a poor risk for participation in this trial.
  • Prior allergic reaction to chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies (HAMA).
  • Subjects receiving a prior investigational agent within 30 days.
  • Prior therapy with oxaliplatin, cetuximab, or prior therapy that targets the EGF pathway.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
  • Mutation in the KRAS gene
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NYU# 04-10 H11817
CA225056 ( Other Identifier: Bristol-Myers Squibb )
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
New York University School of Medicine
New York University School of Medicine
  • ImClone LLC
  • Bristol-Myers Squibb
Principal Investigator: Deirdre Cohen, MD New York University School of Medicine
New York University School of Medicine
February 2018

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