Primary Outcome Measures:
- To assess the response rate of patients with previously treated CRC [ Time Frame: every 6 - 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To measure time to progression [ Time Frame: every 6 - 8 weeks ] [ Designated as safety issue: No ]
- To measure the duration of response for responding patients. [ Time Frame: every 6 - 8 weeks ] [ Designated as safety issue: No ]
- To characterize the quantitative and qualitative toxicities in this patient population. [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
- To study the effect of cetuximab on serial serum EGF levels, over expression of EGFR pathways and downstream markers on tumor tissue (STAT, mutant EGFR and MAPK) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To characterize the pharmacokinetics of cetuximab given on a every 2 week schedule [ Time Frame: monthly ] [ Designated as safety issue: No ]
Intervention Details:
Drug: Cetuximab
The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.
Drug: Irinotecan
The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.
Primary Objective:
·The primary aim of this study is to assess the response rate of patients with previously treated CRC Number of Subjects: 31
Study Population:
Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC.
Test Product, Dose and Mode of Administration, Duration of Treatment:
Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Reference Therapy, Dose and Mode of Administration, Duration of Treatment: Irinotecan administered at a dose of 150a or 180 mg/m2 IV over 60 minutes every two weeks.