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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00661154
First received: April 14, 2008
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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 Intervention
Colorectal Neoplasms
Colon Cancer
Rectal Cancer
Anal Cancer
Drug: Bevacizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: February 2008
Study Completion Date: July 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    2-12microCi IV injection
    Other Name: Avastin
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with metastatic (stage IV) colorectal cancer

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661154

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Genentech
Investigators
Principal Investigator: Dr Andrew Quon Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00661154     History of Changes
Other Study ID Numbers: GIIMG0001, 97291, AVF3679s
Study First Received: April 14, 2008
Last Updated: August 8, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014