Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy

Colon Cancer Clinical Trial

Official title: A Phase 2 Study of Irinotecan and Cetuximab on an Every 2 Week Schedule, as Second Line Therapy in Patients With Advanced Colorectal Cancer

Status Completed

Clinical Trial Summary

Research Hypothesis: Subjects in the study population who are treated with cetuximab in combination with irinotecan will have higher response rates than subjects treated with irinotecan alone.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms
• Rectum Cancer

• NCT number: NCT00336856
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: Phase 2
• Start date: June 2006
• Completion date: June 2011