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A Study of Mitomycin C, Irinotecan, and Cetuximab

NCT ID: NCT00271011

Last Updated: 2015-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mitomycin C

Intervention Type DRUG

Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.

Cetuximab

Intervention Type DRUG

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.

Irinotecan.

Intervention Type DRUG

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.

Interventions

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Mitomycin C

Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Mutamycin® (trade name) Erbitux (trade name) Camptosar (trade name)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Zalupski, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM 00000749

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2005-060

Identifier Type: -

Identifier Source: org_study_id