Back to resultsA Study of Mitomycin C, Irinotecan, and Cetuximab
Primary Purpose
Colorectal Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mitomycin C
Cetuximab
Irinotecan.
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- University of Michigan Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mitomycin C, Irinotecan and Cetuximab
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Patients With an Objective Response
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
Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events
The proportion of patients experiencing hematological and non-hematological toxicities will be summarized.
Full Information
NCT ID
NCT00271011
First Posted
December 27, 2005
Last Updated
November 4, 2015
Sponsor
University of Michigan Rogel Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00271011
Brief Title
A Study of Mitomycin C, Irinotecan, and Cetuximab
Official Title
A Phase II Study of Mitomycin C, Irinotecan and Cetuximab in Patients With Previously Treated, Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
The study was discontinued due to the death of a co-investigator and a second co-investigator leaving the institution.
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mitomycin C, Irinotecan and Cetuximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mitomycin C
Other Intervention Name(s)
Mutamycin® (trade name)
Intervention Description
Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux (trade name)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Irinotecan.
Other Intervention Name(s)
Camptosar (trade name)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients With an Objective Response
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events
Description
The proportion of patients experiencing hematological and non-hematological toxicities will be summarized.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Zalupski, M.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Mitomycin C, Irinotecan, and Cetuximab
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