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CompletedNCT00165568Updated Nov 1, 2009

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

A Phase 2 interventional study of Bevacizumab in Colorectal Cancer and Neoplasm Metastasis, sponsored by Dana-Farber Cancer Institute. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-11-01.

Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Colorectal Cancer
  • Neoplasm Metastasis

Keywords

  • Positron emission tomography
  • PET
  • bevacizumab
  • 5fluorouracil
  • Metastatic colorectal cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 20 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants

Interventions

  • DrugBevacizumab
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. To compare the percent change in tumor flow induced by bevacizumab and fluorouracil

  2. to evaluate the relationship between initial change in tumor radioactivity uptake and retention.

07

Study locations

2 sites
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00165568
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Brigham and Women's Hospital
First posted
Sep 14, 2005
Start date
Jul 2005
Completion
Oct 2006
Last update
Nov 1, 2009

Study contacts

David Ryan, MD
principal investigator · Massachusetts General Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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