Liver MetastasisPhase 2NCT01511146
Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor
A Phase 2 study testing Oxaliplatin and Mitomycin + Gemcitabine in people with Liver Metastasis, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastasis
- What is being tested?
- Oxaliplatin and Mitomycin + Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2011to Jul 2016
- Phase
- Phase 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
- liver metastasis
- solid tumor
Who cannot join
- poor performance
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Herlev Hospital
Herlev, 2730
Ole Larsen, ph.d., MD, +4538682329, olelar02@heh.regionh.dk
Ole Larsen, ph.d., MD
About this study
Official title: Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors
The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.
Read the detailed description
Two regiment are used: N.B. The two regiments will be reported separately
- Mitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be offered patients with solid tumors where all standard treatments have been used. The patients are not allowed to have extrahepatic disease. The purpose of the treatment are to prolonged life.
- FOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only for patients with colorectal cancer where cure is possible but resection straight ahead is not possible. The patients are allowed to have their colorectal cancer in situ for operation latter on. If the patients are KRAS Wild-type, cetuximab are added.
- Conditions
- Liver Metastasis
- Being tested
- Oxaliplatin, Mitomycin + Gemcitabine
- Keywords
- oxaliplatin, mitomycin, gemcitabine, intrahepatic, liver metastasis, response in liver metastasis, downsized to operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called Mitomycin c, Gemcitabine
oxaliplatin 85 mg/m2 in 10 minutes
Mitomycin + GemcitabineDrug
Also called Mitomycin c, Gemcitabine
Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Mitomycin+Gemcitabine | Experimental | Intrahepatic treatment, where all standard treatments have been used Receives: Drug: Oxaliplatin; Drug: Mitomycin + Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.
Measured: 5 years
Secondary outcomes (1)
Progression free survival, adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Finn O Larsen, M.D., Ph.D, Principal investigator, Unaffliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511146
- Sponsor's protocol ID
- AA-1023
- Status last verified
- Jan 2012
- First submitted
- 4 Aug 2011
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors
- ClinicalTrials.gov ID
- NCT01511146
- Acronym / sponsor ID
- AA-1023
- Conditions
- Liver Metastasis
- Keywords
- oxaliplatin, mitomycin, gemcitabine, intrahepatic, liver metastasis, response in liver metastasis, downsized to operation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 18 Jan 2012 (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.
The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.
Detailed description
Two regiment are used: N.B. The two regiments will be reported separately
- Mitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be offered patients with solid tumors where all standard treatments have been used. The patients are not allowed to have extrahepatic disease. The purpose of the treatment are to prolonged life.
- FOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only for patients with colorectal cancer where cure is possible but resection straight ahead is not possible. The patients are allowed to have their colorectal cancer in situ for operation latter on. If the patients are KRAS Wild-type, cetuximab are added.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitomycin+Gemcitabine | Experimental | Drug: Oxaliplatin, Drug: Mitomycin + GemcitabineIntrahepatic treatment, where all standard treatments have been used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- liver metastasis
- solid tumor
Key exclusion criteria (1 listed)
- poor performance
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 |
|---|---|---|
| OxaliplatinAlso: Mitomycin c, Gemcitabineoxaliplatin 85 mg/m2 in 10 minutes | Drug | Mitomycin+Gemcitabine |
| Mitomycin + GemcitabineAlso: Mitomycin c, GemcitabineMitomycin 5 mg/m2 Gemcitabine 1000 mg/m2 | Drug | Mitomycin+Gemcitabine |
Primary outcome
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.
Time frame: 5 years
1 secondary outcome
Progression free survival, adverse events
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 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.
Finn O Larsen, M.D., Ph.D principal investigator
Unaffliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin and Mitomycin + Gemcitabine in people with Liver Metastasis, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jan 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 Denmark. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded. (time frame: 5 years). 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 19 Jan 2012.