Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy
Condition: Colon Cancer; Rectum Cancer
MeSH terms: Colonic Neoplasms; Rectal Neoplasms
Intervention: Cetuximab; Irinotecan
Intervention description: The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.; The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.
Intervention MeSH terms: Irinotecan; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colon Cancer

Summary:

      Research Hypothesis: Subjects in the study population who are treated with cetuximab in
      combination with irinotecan will have higher response rates than subjects treated with
      irinotecan alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must consent to be in the study

          -  Patients must have advanced, surgically unresectable CRC, who have failed a first line
             metastatic regimen, within 12 months of starting protocol therapy.

          -  Patients must have measurable disease

          -  There must be histologic confirmation of adenocarcinoma of the colon or rectum.

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0, 1, or 2

          -  Estimated life expectancy of at least 12 weeks.

          -  One prior therapy for metastatic disease is permitted.

          -  Recurrence within 12 months of adjuvant therapy with FOLFOX or a similar regimen (i.e
             FLOX, CapOX) is considered one regimen and allowed for study

          -  There must be evidence of adequate organ function

          -  Patients with a history of prior non-colorectal malignancies are eligible if they have
             been disease-free for ³ 5 years prior to study entry and are deemed by the physician
             to be at low risk for recurrence.

          -  Age > 18 yrs.

        Exclusion Criteria:

          -  Any prior therapy with irinotecan or cetuximab or an EGFR targeting agent.

          -  Any systemic therapy administered for metastatic or locally recurrent colorectal
             cancer within 28 days of study treatment.

          -  Patients who are considered candidates for surgical resection of metastatic and/or
             locally advanced disease.

          -  Any histology other than adenocarcinoma of the colon or rectum.

          -  Serious concomitant medical conditions that, in the opinion of the investigator, would
             compromise the safety of the patient or compromise the patient's ability to complete
             the study.

          -  Evidence of central nervous system metastases

          -  Pulmonary fibrosis or interstitial pneumonitis

          -  General Medical Concerns

          -  History of other disease, metabolic dysfunction, physical examination finding, or
             clinical laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that might affect the
             interpretation of the results of the study or render the subject at high risk from
             treatment complications.

          -  Serious, uncontrolled, concurrent infection.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, or anticipation of need for major surgical procedure during the course
             of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0.
             Line placement (i.e Infus-a-port or PICC) is not considered major surgery.

          -  Evidence of bleeding diathesis or coagulopathy

          -  Prior severe infusion reaction to a monoclonal antibody.

          -  Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
             unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
             congestive heart failure, and cardiomyopathy with decreased ejection fraction.

          -  Patients with Gilbert's Syndrome

          -  Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of
             the importance of avoiding pregnancy during trial participation and the potential risk
             factors for an unintentional pregnancy. In addition, men enrolled on this study should
             understand the risks to any sexual partner of childbearing potential and should
             practice an effective method of birth control.

          -  All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving
             investigational product. If the pregnancy test is positive, the patient must not
             receive investigational product and must not be enrolled in the study.

          -  In addition, all WOCBP should be instructed to contact the Investigator immediately if
             they suspect they might be pregnant (e.g., missed or late menstrual period) at any
             time during study participation.

          -  The Investigator must immediately notify BMS in the event of a confirmed pregnancy in
             a patient participating in the study.