A Study of Mitomycin C, Irinotecan, and Cetuximab
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Mitomycin C; Cetuximab; Irinotecan.
Intervention description: Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.; Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.; Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2.
Intervention MeSH terms: Irinotecan; Cetuximab; Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Colorectal cancer (CRC) is one of the more common cancers in the United States with over
      145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some
      who relapse after surgery, or are unable to have surgery, chemotherapy is the primary
      treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by
      themselves, but many are given in combination with other chemotherapy treatment drugs and
      they seem to work better together than by themselves. This study will investigate the
      effectiveness of the combination of three chemotherapy drugs in patients who have been
      previously treated for their CRC and it has returned. This study will also evaluate any rash
      that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C,
      Irinotecan, and Cetuximab.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pathologic diagnosis of colorectal cancer.

          2. Clinical and/or radiologic evidence of metastatic disease.

          3. One previous systemic treatment for metastatic disease.

          4. Age > 18.

          5. Presence of at least one measurable lesion.

          6. Adequate hematopoetic (absolute neutrophil count > 1500/mm3, platelet count >
             100,000/mm3), renal (serum creatinine < 1.5 mg/dl), and hepatic function (bilirubin <
             1.5 and transaminases < 5.0 x upper normal limit).

          7. ECOG performance status 0-2.

          8. Life expectancy > 3 months.

          9. Patients must be informed of the investigational nature of this study and provide
             written informed consent in accordance with the institutional and federal guidelines
             prior to the initiation of therapy.

        Exclusion Criteria:

          1. No recognized brain metastasis.

          2. No previous treatment with mitomycin C or cetuximab.

          3. No other systemic malignancy requiring treatment within the past one year.

          4. Pregnant or lactating women may not participate. Women/men of reproductive potential
             must agree to use an effective contraceptive method.

          5. Patients must have no other serious medical or psychiatric illness that would limit
             the ability of the patient to receive protocol therapy or provide informed consent.