Status:
TERMINATED
A Study of Mitomycin C, Irinotecan, and Cetuximab
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 s...
Detailed Description
We propose a phase II trial which combines mitomycin C, irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer with wild type non mutated K-Ras. The goals of this in...
Eligibility Criteria
Inclusion
- Pathologic diagnosis of colorectal cancer.
- Clinical and/or radiologic evidence of metastatic disease.
- One previous systemic treatment for metastatic disease.
- Age \> 18.
- Presence of at least one measurable lesion.
- 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).
- ECOG performance status 0-2.
- Life expectancy \> 3 months.
- 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
- No recognized brain metastasis.
- No previous treatment with mitomycin C or cetuximab.
- No other systemic malignancy requiring treatment within the past one year.
- Pregnant or lactating women may not participate. Women/men of reproductive potential must agree to use an effective contraceptive method.
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00271011
Start Date
December 1 2005
End Date
July 1 2009
Last Update
December 3 2015
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48104