Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project

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Brief Title

Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project

Official Title

Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project

Brief Summary

      To determine whether using a radiolabelled analog of 5-FU, [18F]-5-fluorouracil, for PET/CT
      imaging can visually demonstrate differential chemotherapy delivery to known tumor sites
      before and after administration of bevacizumab and determine the optimal timing of
      bevacizumab administration to maximize the chemotherapy delivery into the tumor for improved
      cancer treatment.

Study Type


Primary Outcome

Determine whether[18F]-5-Fluorouracil PET/CT scanning can demonstrate a difference in [18F]-5-Fluorouracil tumor uptake before and after the administration of Avastin

Secondary Outcome

 Determine if [18F]-5-Fluorouracil PET/CT imaging demonstrates that there is a difference in maximal [18F]-5-Fluorouracil tumor uptake that is dependent on the time point of post-Avastin scanning


Colorectal Neoplasms




* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

February 2008

Completion Date

July 2010

Primary Completion Date

July 2009

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed adenocarcinoma of the

          2. Patients must have metastatic disease to the liver with at least one lesion that is
             measurable by RECIST criteria within 4 weeks prior to entry of study

          3. Patients with a history of colon adenocarcinoma treated by surgical resection who
             develop radiological or clinical evidence of metastatic cancer do not require separate
             histological or cytological confirmation of metastatic disease unless an interval of >
             5 years has elapsed between the primary surgery and the development of metastatic
             disease. Clinicians should consider biopsy of lesions to establish diagnosis of
             metastatic colon adenocarcinoma if there is substantial clinical ambiguity regarding
             the nature or source of apparent metastases.

          4. Patients must have ECOG performance status of 0-2

          5. Patients must be >= 18 years of age

          6. Laboratory values <= 2 weeks prior to enrollment:

               -  Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L (>= 1500/mm^3)

               -  Platelets (PLT) >= 100 x 10^9/L >= 100,000/mm^3)

               -  Hemoglobin (Hgb) >= 9 g/dL

               -  Serum creatinine <= 1.5 ULN

               -  Serum bilirubin <= 1.5 ULN

               -  Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) <=
                  3.0 x ULN (<= 5 x ULN if liver metastases present). Note: ERCP or percutaneous
                  stenting may be used to normalize the liver function tests.

               -  Negative for proteinuria based on dip stick reading OR, if documentation of +1
                  result for protein on dip stick reading, then total urinary protein <= 500 mg and
                  measured creatinine clearance (CrCl) >= 50 mL/min from a 24-hour urine collection

          7. Life expectancy >= 12 weeks

          8. Ability to give written informed consent according to local guidelines

        Exclusion Criteria:

          1. Patients receiving prior 5-FU for the treatment of metastatic colorectal
             adenocarcinoma will be excluded from enrollment. Previous use of 5-FU for adjuvant
             treatment of resected stage II or III colorectal adenocarcinoma will be allowed,
             provided the time from last 5-FU administration to enrollment is > 3 months.

          2. Prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks
             prior to enrollment. Patients must have recovered from all therapy-related toxicities.
             The site of previous radiotherapy should have evidence of progressive disease if this
             is the only site of disease.

          3. Prior biologic or immunotherapy <= 2 weeks prior to registration. Patients must have
             recovered from all therapy-related toxicities

          4. Prior therapy with anti-VEGF agents

          5. Patients with a history of another primary malignancy <= 5 years, with the exception
             of inactive basal or squamous cell carcinoma of the skin

          6. Concurrent use of other investigational agents and patients who have received
             investigational drugs <= 4 weeks prior to enrollment.

          7. Female patients who are pregnant or breast feeding, or adults of reproductive
             potential not employing an effective method of birth control. Barrier contraceptives
             must be used throughout the trial in both sexes. Women of childbearing potential must
             have a negative serum pregnancy test 48 hours prior to administration of study

          8. Patients unwilling to or unable to comply with the protocol




18 Years - N/A

Accepts Healthy Volunteers



Dr Andrew Quon, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

Stanford University


 Genentech, Inc.

Study Sponsor

Dr Andrew Quon, Principal Investigator, Stanford University

Verification Date

August 2012