Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00336856
Brief 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.
Detailed Description:
Primary Objective:
·The primary aim of this study is to assess the response rate of patients with previously treated colorectal cancer (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:
NCT00336856
Study Brief:
Protocol Section:
NCT00336856