Clinical trial NCT00271011: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-12-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Patients With an Objective Response
timeFrame: 2 months
Secondary outcomes:
measure: Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events
timeFrame: 2 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Mark Zalupski, M.D.
role: PRINCIPAL_INVESTIGATOR
References: