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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661154
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : August 10, 2012
Genentech, Inc.
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment
Colorectal Neoplasms Colon Cancer Rectal Cancer Anal Cancer Drug: Bevacizumab

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project
Study Start Date : February 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Bevacizumab
    2-12microCi IV injection
    Other Name: Avastin

Primary Outcome Measures :
  1. 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 [ Time Frame: 1-4 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 1-4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with metastatic (stage IV) colorectal cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661154

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Genentech, Inc.
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Principal Investigator: Dr Andrew Quon Stanford University

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Responsible Party: Stanford University Identifier: NCT00661154     History of Changes
Other Study ID Numbers: GIIMG0001
97291 ( Other Identifier: Stanford University Alternate IRB Number )
AVF3679s ( Other Identifier: Genentech )
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
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Colorectal Neoplasms
Anus Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Anus Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors