Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: cetuximab with irinotecan
Intervention description: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
Intervention MeSH terms: Irinotecan; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Colorectal cancer; KRAS wild type tumors

Summary:

      This study is being performed to test if the use of high dose of cetuximab in combination
      with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan
      in patients with wild type KRS tumors that have advanced colon or rectal cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed colon cancer that is metastatic or unresectable

          -  Progressed on cetuximab plus irinotecan based combination prior to enrolling on this
             study

          -  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 document.

          -  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
             treatment

          -  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