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

October 30, 2009 updated by: Dana-Farber Cancer Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Metastatic colorectal cancer subjects
  • Subjects must have at least one non-radiated FDG-glucose avid (as demonstrated by an FDG-glucose PET scan) liver metastasis of at least 2 cm in size.
  • Subjects must have never received chemotherapy for metastatic disease; subjects may have received adjuvant chemotherapy for presumed early stage disease if it was completed at least 12 months prior to study entry date
  • All subjects must have already consented to an on-label use of a BV and fluorouracil containing first-line chemotherapy regimen (either with irinotecan or oxaliplatin) and must be a candidate for such a therapy as defined by the enrolling investigator and the community standard of care. As such a chemotherapy regimen requires an infusion port, this port should be placed at least two weeks prior to the subject's first dose of bevacizumab.
  • Chronological age ≥ 18 years.
  • ECOG performance status ≤ 2.
  • Life expectancy ≥ 12 weeks.
  • Women must not be pregnant or lactating. Both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study.
  • Subjects with concurrent malignancy of any site are eligible if the disease is under adequate control.
  • All subjects must sign informed consent.

Exclusion Criteria:

  • Subjects in "visceral crises", meaning a delay in achieving tumor response by 2 weeks may result in organ failure, are ineligible for this study.
  • Subjects who are planned to undergo treatment with fluorouracil and bevacizumab alone (without irinotecan or oxaliplatin) are ineligible for this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the percent change in tumor radioactivity uptake and retention after radiolabeled fluorouracil administration in subjects who receive bevacizumab versus those who do not receive bevacizumab.

Secondary Outcome Measures

Outcome Measure
To compare the percent change in tumor flow induced by bevacizumab and fluorouracil
to evaluate the relationship between initial change in tumor radioactivity uptake and retention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Brigham and Women's Hospital

Investigators

  • Principal Investigator: David Ryan, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

November 1, 2009

Last Update Submitted That Met QC Criteria

October 30, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-415

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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