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A Phase II Study of High Dose Cetuximab Plus Irinotecan in Colorectal Cancer Patients With KRS-Wild Type Tumors Who Progressed After Failure of Prior Standard Dose ofCetuximab Plus Irinotecan

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Phase II Study of High Dose Cetuximab Plus Irinotecan in Colorectal Cancer Patients With KRS-Wild Type Tumors Who Progressed After Failure of Prior Standard Dose ofCetuximab Plus Irinotecan

Cetuximab is a manufactured antibody-antibodies are proteins that can be found circulating
in your blood stream. The growth of colorectal cancer may be affected by the interaction of
a growth factor known as "epidermal growth factor" (EGF) with its receptor.

Cetuximab is a antibody directed against the receptor for EGF and has been shown to turn off
the activity of the receptor and to stop the growth of cancer cells in many laboratory
tests. Cetuximab has been recently approved by the Food and Drug Administration in the
treatment of patients with advanced colorectal cancer and who failed standard chemotherapy.
Cetuximab has been shown to delay the progression of colorectal cancer when given alone in
patients who have failed standard chemotherapy and when given with a chemotherapy drug
called irinotecan in patients who have failed irinotecan.

Inclusion Criteria:

- Histologically confirmed colon cancer that is metastatic or unresectable

- Progressed on cetuximab plus irinotecan based combination prior to enrolling on this

- Patient must have tumor tissue tested for KRAS mutation and should be confirmed to
carry a wild type

- ECOG less than or equal to 1

- Must have adequate organ and marrow function

- Ability to understand and the willingness to sign a written informed consent

- Presence of measurable disease defined as a lesion ≥ 2 cm by CT (or 1 cm by spiral
CT). All sites of disease should be evaluated ≤ 3 weeks before treatment initiation

- Patients should have failed or been deemed intolerant to other standard chemotherapy
treatments such as oxaliplatin and fluoropyrimidines

Exclusion Criteria:

- Patients may not be receiving any other investigational agents that are not included
in this study. Prior investigational anticancer agents wil not be allowed within 4
weeks prior to study treatment. Herbal medicine and vitamins wil not be considered as
contraindications for enrollment on study.

- Patients with known brain metastases are not eligible unless brain metastases are
treated and stable on radiographic follow-up and without significant symptomatology

- History of other invasive cancers with current evidence of disease

- Patients should be off chemotherapy or other targeted therapies for at least 3 weeks
before study treatment. Mitomycin C treatment should be at least 6 weeks before study

- History of allergic reactions to irinotecan

- Prior severe infusion reaction to cetuximab

- History of allergic reaction to tetracycline or doxycycline

- Need for prior dose reduction on cetuximab secondary to grade 3 skin toxicity

- Active skin toxicity of grade 2 or higher at the time of study enrollment

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements.

- Pregnant women are excluded from this study because the chemotherapeutic agents
proposed are category D agents with the potential for teratogenic or abortifacient
effects. Because there is an unknown but potential risk for adverse events in nursing
infants secondary to treatment of the mother with chemotherapy, breastfeeding should
be discontinued if the mother is treated on this study.

- Grade 2 or higher hypomagnesemia at baseline evaluation

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the rate of 12-week progression free survival rate upon escalation of cetuximab dose to 500mg/m2 in combination with irinotecan after progression on standard dose therapy in patients with KRS wild type colorectal cancer

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

WenWee Ma, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:

I 152009



Start Date:

September 2009

Completion Date:

February 2013

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • KRAS wild type tumors
  • Colorectal Neoplasms



Roswell Park Cancer InstituteBuffalo, New York  14263