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A Study of Mitomycin C, Irinotecan, and Cetuximab

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ClinicalTrials.gov Identifier: NCT00271011
Recruitment Status : Terminated (The study was discontinued due to the death of a co-investigator and a second co-investigator leaving the institution.)
First Posted : December 29, 2005
Results First Posted : July 10, 2014
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
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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 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 or disease Intervention/treatment Phase
Colorectal Cancer Drug: Mitomycin C Drug: Cetuximab Drug: Irinotecan. Phase 2

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 investigation are to develop an effective systemic therapy for previously treated patients with CRC with wild type K-Ras, to further explore the relationship of mitomycin C induced topoisomerase 1 gene expression and response to irinotecan, and to define and characterize the biology of cetuximab induced skin rash.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2009

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Arms and Interventions
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Arm Intervention/treatment
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
Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
Other Name: Mutamycin® (trade name)

Drug: Cetuximab
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.
Other Name: Erbitux (trade name)

Drug: Irinotecan.
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.
Other Name: Camptosar (trade name)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients With an Objective Response [ Time Frame: 2 months ]
    The primary objective of this single-arm phase II study is to determine the response rate (Percentage patients with Complete Response (CR) + Percentage of patients with Partial Response (PR)) for the combination of mitomycin C, irinotecan, and cetuximab in metastatic colorectal cancer with wild type K-Ras. Complete response will be defined as the disappearance of all measurable and evaluable disease for at least 4 weeks without the appearance of new lesions. Partial response will be defined as a decrease in the sum of the longest diameter of target lesions by at least 30% for at least 4 weeks without the appearance of any new lesions.


Secondary Outcome Measures :
  1. Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events [ Time Frame: 2 months ]
    The proportion of patients experiencing hematological and non-hematological toxicities will be summarized.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271011


Locations
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United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Mark Zalupski, M.D. University of Michigan Rogel Cancer Center
More Information
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00271011    
Other Study ID Numbers: UMCC 2005-060
HUM 00000749 ( Other Identifier: University of Michigan IRBMED )
First Posted: December 29, 2005    Key Record Dates
Results First Posted: July 10, 2014
Last Update Posted: December 3, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
 Cetuximab
Mitomycins
Mitomycin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors