A Study of Mitomycin C, Irinotecan, and Cetuximab

NCT00271011 | Terminated Phase 2 Results DMC

• 2 other identifiers: UMCC 2005-060HUM 00000749
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (1)

• Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events

  2 months

Study Arms (1)

Mitomycin C, Irinotecan and Cetuximab

EXPERIMENTAL

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.

Interventions

Mitomycin C DRUG

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

Also known as: Mutamycin® (trade name)

Mitomycin C, Irinotecan and Cetuximab

Cetuximab 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.

Also known as: Erbitux (trade name)

Mitomycin C, Irinotecan and Cetuximab

Irinotecan. 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.

Also known as: Camptosar (trade name)

Mitomycin C, Irinotecan and Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Mitomycin; Cetuximab; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids

Limitations and Caveats

The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution.

Results Point of Contact

• Title: Dr. Mark Zalupski
• Organization: University of Michigan Comprehensive Cancer Center

zalupski@umich.edu

734-615-3969

Study Officials

• Mark Zalupski, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2005
• First Posted: December 29, 2005
• Study Start: December 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2009
• Last Updated: December 3, 2015
• Results First Posted: July 10, 2014

Record last verified: 2015-11

Locations

US (1)