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A Study of Mitomycin C, Irinotecan, and Cetuximab
This study is currently recruiting participants.
Verified by University of Michigan Cancer Center, October 2008
Sponsored by: University of Michigan Cancer Center
Information provided by: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00271011
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer (CRC)
Drug: Mitomycin C
Drug: Cetuximab
Drug: Irinotecan.
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Irinotecan Irinotecan hydrochloride Cetuximab Mitomycin Mitomycins
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Mitomycin C, Irinotecan and Cetuximab in Patients With Previously Treated, Metastatic Colorectal Cancer

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • response [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: December 2005
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271011

Contacts
Contact: Cancer Answer Line 1-800-865-1125

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Cancer Answer Line     800-865-1125        
Principal Investigator: Mark Zalupski, M.D.            
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Mark Zalupski, M.D. University of Michigan Cancer Center
  More Information

Responsible Party: University of Michigan Health Systems ( Dr. Mark Zalupski )
Study ID Numbers: UMCC 2005-060, HUM 00000749
Study First Received: December 27, 2005
Last Updated: October 10, 2008
ClinicalTrials.gov Identifier: NCT00271011  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Cetuximab
Intestinal Diseases
Rectal Diseases
Mitomycins
Intestinal Neoplasms
Digestive System Diseases
Mitomycin
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009