Using Positron Emission Tomography to Evaluate the Effects of Bevacizumab on Intra-tumoral Pharmacokinetics of 5-fluorouracil in Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title: Using Positron Emission Tomography to Evaluate the Effects of Bevacizumab on Intra-tumoral Pharmacokinetics of 5-fluorouracil in Metastatic Colorectal Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate whether bevacizumab helps 5-Fluorouracil (5-FU) be delivered to the tumor more efficiently. Bevacizumab has been shown to inhibit the formation of new blood vessels in tumors and works best in combination with drugs that require blood vessels for transportation. Based on other experiments, bevacizumab may work by improving the transportation of other drugs to the tumor.

Clinical Trial Description

• This is not a treatment study. A treatment regimen has already been decided upon by the patient and doctor.

• At the screening visit for this trial the following will be performed: a medical history, physical examination, CT scan to measure the amount and size of the tumor(s), and a PET scan using glucose that has been attached to a small amount of radioactivity to determine how well the tumor takes up glucose.

• Patients will then be randomized into one of 2 treatment groups. Group 1 will receive both 5-FU and bevacizumab on the first day of chemotherapy. Group 2 will receive just 5-FU on the first day of chemotherapy.

• Patients will undergo a PET scan that uses water that has been attached to a small amount of radioactivity to measure how well the tumor takes up water prior to the 5-FU adminstration.

• After patients receive 5-Fu they will undergo a PET scan during which a small amount of 5-FU has been attached to a small amount of radioactivity to measure how well the tumor takes up 5-FU. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

• NCT number: NCT00165568
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 2
• Start date: July 2005
• Completion date: October 2006