Colorectal NeoplasmsNCT00661154
Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project
An observational study of Colorectal Neoplasms and Colon Cancer, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Colon Cancer, Rectal Cancer
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with metastatic (stage IV) colorectal cancer
Who may be able to join
- Patients must have histologically or cytologically confirmed adenocarcinoma of the colon.
- 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:
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
- Conditions
- Colorectal Neoplasms, Colon Cancer, Rectal Cancer, Anal Cancer
- Being tested
- Bevacizumab
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
2-12microCi IV injection
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Dr Andrew Quon, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661154
- Sponsor's protocol ID
- GIIMG0001
- Other IDs
- 97291, AVF3679s
- Status last verified
- Aug 2012
- First submitted
- 14 Apr 2008
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project
- ClinicalTrials.gov ID
- NCT00661154
- Acronym / sponsor ID
- GIIMG0001
- Conditions
- Colorectal Neoplasms, Colon Cancer, Rectal Cancer, Anal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with metastatic (stage IV) colorectal cancer
Key inclusion criteria (15 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the colon.
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin2-12microCi IV injection | Drug | – |
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
Time frame: 1-4 days
1 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
Time frame: 1-4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Andrew Quon principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Colon Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.