NCT00661154

Completed

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

Stanford University Source

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Other study identifiers

Sponsor study identifier

GIIMG0001

Secondary identifiers

97291

OTHER · Stanford University Alternate IRB Number

AVF3679s

OTHER · Genentech

Study Type

observational

Actual enrollment (reported)

7

Locations

1 country

Sites

1

Timeline

Study Start

February 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2009

Actual (reported)

Study Completion

July 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 7 participants
Study completion date: July 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
April 14, 2008
Actual (reported)
First Posted
April 18, 2008
Actual (reported)
Primary Completion
July 2009
Actual (reported)
Study Completion
July 2010
Actual (reported)

Last Updated: August 10, 2012
Status Verified: August 2012
Last Update Submitted: August 8, 2012

Conditions

Anal Cancer Colon Cancer Colorectal Neoplasms Rectal Cancer

Outcome Measures

Primary Outcomes (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
1-4 days

Secondary Outcomes (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
1-4 days

Interventions

BevacizumabDrug

2-12microCi IV injection

Also known as: Avastin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients diagnosed with metastatic (stage IV) colorectal cancer

You may qualify if:

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

Sponsors & Collaborators

Stanford University
Otherlead
Genentech, Inc.
Industrycollaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal NeoplasmsAnus Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

Dr Andrew Quon
Stanford University
PRINCIPAL INVESTIGATOR

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 18, 2008

Study Start

February 2008

Date type not reported

This date has not been verified as actual or estimated.

NCT00165568

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

Phase 2Completed

NCT00674011

Hypertension in Breast Cancer Patients Receiving Bevacizumab

Terminated

NCT00469469

Treatment Study Using Bevacizumab for Patients With Adrenocortical Carcinoma

Phase 2Withdrawn

NCT00667277

Phase II Study of Bevacizumab (Avastin®) in Myelofibrosis

Phase 2Terminated

NCT00559936

Topical Avastin for Treatment of Corneal Neovascularization

Phase 1Completed

NCT00846612

Pharmacokinetic Study of Avastin and Doxil in Ovarian Cancer

Phase 1Completed

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

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.

Patients must have ECOG performance status of 0-2

Patients must be \>= 18 years of age

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

Life expectancy \>= 12 weeks

Ability to give written informed consent according to local guidelines

You may not qualify if:

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.
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.
Prior biologic or immunotherapy \<= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
Prior therapy with anti-VEGF agents
Patients with a history of another primary malignancy \<= 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin
Concurrent use of other investigational agents and patients who have received investigational drugs \<= 4 weeks prior to enrollment.
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.
Patients unwilling to or unable to comply with the protocol

Contact the study team to confirm eligibility.

Rectal Diseases

Anus Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Primary Completion

July 2009

Actual (reported)

Study Completion

July 2010

Actual (reported)

Last Updated

August 10, 2012

Record last verified: 2012-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00661154
Data provider: ClinicalTrials.gov
Source updated: 2012-08-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:52 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations