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A Study of Mitomycin C, Irinotecan, and Cetuximab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00271011
First received: December 27, 2005
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Mitomycin C, Irinotecan and Cetuximab in Patients With Previously Treated, Metastatic Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 13
Study Start Date: December 2005
Study Completion Date: July 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mitomycin C, Irinotecan and Cetuximab

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.

 Drug: Mitomycin C Drug: Cetuximab Drug: Irinotecan.

  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

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Mark Zalupski, M.D. University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00271011     History of Changes
Other Study ID Numbers: UMCC 2005-060, HUM 00000749
Study First Received: December 27, 2005
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Mitomycins
Mitomycin
Irinotecan
 Cetuximab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013