Colorectal CancerPhase 1/2NCT00244348
Hepatic Artery Infusion With Oxaliplatin
A Phase 1/2 study testing Oxaliplatin (via HAI) and 5 Fluorouracil (systemic) in people with Colorectal Cancer and Metastasis, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Hepatic artery infusion (HAI) with oxaliplatin (OX), systemic 5 fluorouracil (5FU), and leucovorin (HAI/OX/FU) will be implemented using an interventional radiology technique to obviate the need for initial major surgery (catheter placement) in patients who have unresectable liver metastasis from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastasis, Liver Cancer
- What is being tested?
- Oxaliplatin (via HAI) and 5 Fluorouracil (systemic)
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Aug 2015
- Phase
- Phase 1/2
- 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
Who may be able to join
- Signed consent
- Age greater than 17 years
- Stage IV colorectal cancer
- Metastasis limited to the liver considered unresectable for cure by standard methods
- Completely resected primary tumor
- Life expectancy greater than 3 years excluding cancer
Show all 11Show fewer
- Eastern Cooperative Oncology Group (ECOG) status 0, 1, 2
- Absolute granulocyte count greater than 1500
- Platelet count greater than 100,000
- Adequate hepatic function
- Adequate renal function
Who cannot join
- Concomitant anticancer therapy other than this protocol
- Gastroduodenal ulcer
- Pregnancy or lactation
- Last treatment for colon cancer less than 4 weeks from this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Hepatic Arterial Infusion of Oxaliplatin Clinical Trial
Hepatic artery infusion (HAI) with oxaliplatin (OX), systemic 5 fluorouracil (5FU), and leucovorin (HAI/OX/FU) will be implemented using an interventional radiology technique to obviate the need for initial major surgery (catheter placement) in patients who have unresectable liver metastasis from colorectal cancer. The study goal is to reduce tumor size to make possible a complete resection of all lesions. Secondary goals are to reduce or eliminate the complexity usually associated with HAI, to accomplish most or all of the treatment as an outpatient, to reduce costs, and to avoid the hepatotoxicity associated with HAI/floxuridine (FUDR). Oxaliplatin has been selected because of its ease of use, known toxicology, and established efficacy in colorectal cancer.
Read the detailed description
After entry qualification and registration patients will undergo hepatic artery catheterization via interventional radiology. The catheter will remain in place for two hours while oxaliplatin is infused and then be removed. This treatment will be followed by a 48 hour infusion of 5FU and leucovorin, generally following the principle of FOLFOX 6. These cycles of therapy will be repeated biweekly for six episodes. Hepatic tumor size will be evaluated by CT scan to determine if resectability has been established as the result of tumor size reduction. If so, the patient will be offered resection of the residual lesions in an effort to achieve long term survival.
- Conditions
- Colorectal Cancer, Metastasis, Liver Cancer
- Being tested
- Oxaliplatin (via HAI), 5 Fluorouracil (systemic)
- Keywords
- hepatic artery infusion, colorectal cancer, liver metastasis, oxaliplatin, 5 fluorouracil
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin (via HAI)Drug
5 Fluorouracil (systemic)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who become eligible for total resection of metastatic liver tumor
overall survival of patients resected for cure versus (vs.) resected for palliation vs. not resected.
Secondary outcomes (3)
toxicity
HAI complexity
cost
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionAug 2015 (estimated)
- Study completionAug 2015
Why it stopped: Investigator has left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Investigators
- Robert K Ausman, M. D., Principal investigator, Dept. Surgery, Medical College of WisconsinEdward J Quebbeman, M. D., Principal investigator, Dept. Surgery, Medical College of WisconsinWilliam S Rilling, M. D., Principal investigator, Dept. Radiology, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244348
- Sponsor's protocol ID
- HRRC#341-05
- Status last verified
- Aug 2015
- First submitted
- 25 Oct 2005
- Last updated
- 27 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion of Oxaliplatin Clinical Trial
- ClinicalTrials.gov ID
- NCT00244348
- Acronym / sponsor ID
- HRRC#341-05
- Conditions
- Colorectal Cancer, Metastasis, Liver Cancer
- Keywords
- hepatic artery infusion, colorectal cancer, liver metastasis, oxaliplatin, 5 fluorouracil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator has left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (actual)
- First posted
- 26 Oct 2005 (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.
Hepatic artery infusion (HAI) with oxaliplatin (OX), systemic 5 fluorouracil (5FU), and leucovorin (HAI/OX/FU) will be implemented using an interventional radiology technique to obviate the need for initial major surgery (catheter placement) in patients who have unresectable liver metastasis from colorectal cancer. The study goal is to reduce tumor size to make possible a complete resection of all lesions. Secondary goals are to reduce or eliminate the complexity usually associated with HAI, to accomplish most or all of the treatment as an outpatient, to reduce costs, and to avoid the hepatotoxicity associated with HAI/floxuridine (FUDR). Oxaliplatin has been selected because of its ease of use, known toxicology, and established efficacy in colorectal cancer.
Detailed description
After entry qualification and registration patients will undergo hepatic artery catheterization via interventional radiology. The catheter will remain in place for two hours while oxaliplatin is infused and then be removed. This treatment will be followed by a 48 hour infusion of 5FU and leucovorin, generally following the principle of FOLFOX 6. These cycles of therapy will be repeated biweekly for six episodes. Hepatic tumor size will be evaluated by CT scan to determine if resectability has been established as the result of tumor size reduction. If so, the patient will be offered resection of the residual lesions in an effort to achieve long term survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed consent
- Age greater than 17 years
- Stage IV colorectal cancer
- Metastasis limited to the liver considered unresectable for cure by standard methods
- Completely resected primary tumor
Key exclusion criteria (4 listed)
- Concomitant anticancer therapy other than this protocol
- Gastroduodenal ulcer
- Pregnancy or lactation
- Last treatment for colon cancer less than 4 weeks from this protocol
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 |
|---|---|---|
| Oxaliplatin (via HAI) | Drug | – |
| 5 Fluorouracil (systemic) | Drug | – |
Primary outcome
number of patients who become eligible for total resection of metastatic liver tumor
overall survival of patients resected for cure versus (vs.) resected for palliation vs. not resected.
3 secondary outcomes
toxicity
HAI complexity
cost
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
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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.
Robert K Ausman, M. D. principal investigator
Dept. Surgery, Medical College of Wisconsin
Edward J Quebbeman, M. D. principal investigator
Dept. Surgery, Medical College of Wisconsin
William S Rilling, M. D. principal investigator
Dept. Radiology, Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oxaliplatin (via HAI) and 5 Fluorouracil (systemic) in people with Colorectal Cancer and Metastasis, run by Medical College of Wisconsin 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 11 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 Aug 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
number of patients who become eligible for total resection of metastatic liver tumor. The study lists 2 primary outcomes in all. 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 27 Aug 2015.