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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Neoplasm Metastasis

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Trial Information

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


- 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.


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.

Type of Study:

Interventional

Study Design:

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

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.

Principal Investigator

David Ryan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

04-415

NCT ID:

NCT00165568

Start Date:

July 2005

Completion Date:

October 2006

Related Keywords:

  • Colorectal Cancer
  • Neoplasm Metastasis
  • Positron emission tomography
  • PET
  • bevacizumab
  • 5fluorouracil
  • Metastatic colorectal cancer
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617