A Study of Mitomycin C, Irinotecan, and Cetuximab

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Camptothecin; Cetuximab; Irinotecan; Mitomycin; Mitomycins

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.