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A Phase II Study of Mitomycin C, Irinotecan and Cetuximab in Patients With Previously Treated, Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer (CRC)

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Trial Information

A Phase II Study of Mitomycin C, Irinotecan and Cetuximab in Patients With Previously Treated, Metastatic Colorectal Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Mark Zalupski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2005-060

NCT ID:

NCT00271011

Start Date:

December 2005

Completion Date:

July 2009

Related Keywords:

  • Colorectal Cancer (CRC)
  • Colorectal Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752