Metastatic Colorectal CancerPhase 3NCT00396487
Tailored Treatment in Metastatic Colorectal Cancer
A Phase 3 study testing Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat in people with Metastatic Colorectal Cancer, run by Vejle Hospital at 10 sites in Denmark.
Trial summary
To compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase III trial. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat
- How many people
- 1 participants
- Where
- 10 sitesDenmark
- Study dates
- Nov 2006to Feb 2008
- Phase
- Phase 3
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic colorectal cancer
- Histopathological verification of the primary tumor
- Measurable disease according to RESIST criteria
- Single agent chemotherapy indicated
- Performance status >=2
- Age >= 60 years
Show all 10Show fewer
- Life expectancy > 3 months
- Adequate liver and kidney function as evaluated by bilirubin <= 3 times of normal upper limit, ALAT <= 3 times upper normal limit (<= 5 times upper normal limit in case of liver metastases), serum creatinine <= 1.5 times normal upper limit.
- ANC >=1.5 x 109/l and platelets >= 100 x 109/l
- Informed consent
Who cannot join
- Patients with CNS metastases
- Other malignant disease within the last 5 years except for non-melanoma skin cancer and carcinoma in situ of cervix uteri
- Previous chemotherapy for metastatic disease
- Adjuvant chemotherapy < 6 months before inclusion
- Patients with previous major toxic or allergic reaction to the protocol drugs
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Denmark10 sites
Aalborg Hospital
Aalborg, 9100
Aarhus University Hospital
Aarhus, 8000
Rigshospitalet
Copenhagen, 2100
Sydvestjysk Hospital Esbjerg
Esbjerg, 6700
Herlev Hospital
Herlev, 2730
Herning Central Hospital
Herning, 7400
Næstved Hospital
Næstved, 4700
Odense University Hospital
Odense, 5000
Roskilde Hospital
Roskilde, 4000
Viborg Hospital
Viborg, 8800
About this study
Official title: Tailored Treatment of Metastatic Colorectal Cancer Based on Genetic Markers
To compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase III trial.
Read the detailed description
The TS and MTHFR polymorphism has been investigated in a new study based on analysis of normal tissue. The results indicated that protein with a 3/3 TS polymorphism or a MTHFR T polymorphism had a significantly higher response rate and a longer time to progression than the other groups when treated with bolus 5-FU.
Capecitabine is metabolised to 5-FU through a number of enzymatic steps. It is the first rationally designed drug that is based upon the high concentration of thymidine phosphorylase (TP) in many human tumors compared to normal tissue. TP is the last step in the conversion of capecitabine to 5-FU and seems to be the limiting factor for the activation. Capecitabine may to some extent mimic continues 5-FU infusion as opposed to bolus 5-FU. A number of small investigations have indicated that patients with 2R/2R TS polymorphism have a higher response rate than heterozygous patients.
The TS and MTHFR polymorphism analysis can easily be performed on sputum, which means an easy collection and sending of the samples.
At present single agent chemotherapy is based on three drugs (5-FU, capecitabine, and Irinotecan) with almost the same overall activity. It seems rational to investigate if improvement can be obtained by tailoring the treatment according to gene polymorphism.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat
- Keywords
- Metastatic colorectal cancer, tailored treatment, genetic markers, gene polymorphism, chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, Irinotecan, 5-Fluorouracil+CalciumfolinatDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is
Response according to RECIST criteria.
Secondary outcomes (4)
Secondary end points are
Progression free survival
Overall survival
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startNov 2006
- Study completionFeb 2008
Why it stopped: Only one patient included as per Feb. 4, 2008.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, Prof, MDSc, Principal investigator, Department of Oncology, Vejle Hospital, 7100 Vejle, DK-Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396487
- Sponsor's protocol ID
- TT-2006-002957-56
- Status last verified
- Jun 2015
- First submitted
- 6 Nov 2006
- Last updated
- 11 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Treatment of Metastatic Colorectal Cancer Based on Genetic Markers
- ClinicalTrials.gov ID
- NCT00396487
- Acronym / sponsor ID
- TT-2006-002957-56
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, tailored treatment, genetic markers, gene polymorphism, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only one patient included as per Feb. 4, 2008.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Feb 2008 (actual)
- First posted
- 7 Nov 2006 (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 compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase III trial.
Detailed description
The TS and MTHFR polymorphism has been investigated in a new study based on analysis of normal tissue. The results indicated that protein with a 3/3 TS polymorphism or a MTHFR T polymorphism had a significantly higher response rate and a longer time to progression than the other groups when treated with bolus 5-FU.
Capecitabine is metabolised to 5-FU through a number of enzymatic steps. It is the first rationally designed drug that is based upon the high concentration of thymidine phosphorylase (TP) in many human tumors compared to normal tissue. TP is the last step in the conversion of capecitabine to 5-FU and seems to be the limiting factor for the activation. Capecitabine may to some extent mimic continues 5-FU infusion as opposed to bolus 5-FU. A number of small investigations have indicated that patients with 2R/2R TS polymorphism have a higher response rate than heterozygous patients.
The TS and MTHFR polymorphism analysis can easily be performed on sputum, which means an easy collection and sending of the samples.
At present single agent chemotherapy is based on three drugs (5-FU, capecitabine, and Irinotecan) with almost the same overall activity. It seems rational to investigate if improvement can be obtained by tailoring the treatment according to gene polymorphism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Metastatic colorectal cancer
- Histopathological verification of the primary tumor
- Measurable disease according to RESIST criteria
- Single agent chemotherapy indicated
- Performance status >=2
Key exclusion criteria (5 listed)
- Patients with CNS metastases
- Other malignant disease within the last 5 years except for non-melanoma skin cancer and carcinoma in situ of cervix uteri
- Previous chemotherapy for metastatic disease
- Adjuvant chemotherapy < 6 months before inclusion
- Patients with previous major toxic or allergic reaction to the protocol drugs
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 |
|---|---|---|
| Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat | Drug | – |
Primary outcome
The primary end point is
Response according to RECIST criteria.
4 secondary outcomes
Secondary end points are
Progression free survival
Overall survival
Toxicity
Results and safety
The study was stopped early (reason given: Only one patient included as per Feb. 4, 2008.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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.
Anders Jakobsen, Prof, MDSc principal investigator
Department of Oncology, Vejle Hospital, 7100 Vejle, DK-Denmark
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine, Irinotecan, 5-Fluorouracil+Calciumfolinat in people with Metastatic Colorectal Cancer, run by Vejle Hospital at 10 sites 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 10 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: Only one patient included as per Feb. 4, 2008.). Results are not available in the source record.
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?
The primary end point is. 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 11 Jun 2015.