Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Genentech, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Bevacizumab

Phase:

N/A

Eligibility


Inclusion Criteria:

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

   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
   treatment.

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maurice Zissen
6507361365
Not Recruiting