C04.588.274.476.411.307Phase 2/3NCT00212615
XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
A Phase 2/3 study testing Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) in people with C04.588.274.476.411.307, run by Odense University Hospital at 8 sites in 2 countries.
Trial summary
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C04.588.274.476.411.307
- What is being tested?
- Oxaliplatin (Eloxatin) and Capecitabine (Xeloda)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Feb 2004to Oct 2008
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proven adenocarcinoma of the colon or rectum
- Measurable or non-measurable disease
- Performance status 0-2
- Adequate renal and hepatic functions
- Adjuvant chemotherapy must have ended 180 days before inclusion
- Written informed consent prior to randomization
Who cannot join
- Prior treatment with Eloxatin or Xeloda
- Peripheral neuropathy
- Evidence of CNS metastasis
- Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months)
- Past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer
- Administration of any other experimental drug under investigation within 2 weeks before randomisation
- Pregnant or breast feeding women
- Fertile patients must use adequate contraceptives
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Denmark6 sites
Department of Oncology, Esbjerg Hospital
Esbjerg, 6700
Department of Oncology, Herlev University Hospital
Herlev, 2730
Department of Oncology, Herning Hospital
Herning, 7400
Department of Oncology, Hillerød Hospital
Hillerød, 3400
Department of Oncology, Næstved Hospital
Næstved, 4700
Department of Oncology, Roskilde Hospital
Roskilde, 4000
Sweden2 sites
Department of Oncology, Radiumhemmet
Stockholm, 100 26
Department of Oncology, Uppsala University Hospital
Uppsala, 751 85
About this study
Official title: XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).
Bloodsamples will be collected and frozen and later examined for potential predictive factors
- Conditions
- C04.588.274.476.411.307
- Being tested
- Oxaliplatin (Eloxatin), Capecitabine (Xeloda)
- Keywords
- Colorectal neoplasm, Capecitabine (Xeloda), Oxaliplatin (Eloxatin), Advanced disease, Metastatic disease, First-line treatment, Phase II study
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin (Eloxatin)Drug
Capecitabine (Xeloda)Drug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Standard XELOX Receives: Drug: Oxaliplatin (Eloxatin); Drug: Capecitabine (Xeloda) |
| B | Active comparator | Chronomodulated XELOX Receives: Drug: Oxaliplatin (Eloxatin); Drug: Capecitabine (Xeloda) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
Secondary outcomes (6)
Physical examination: before treatment (each 3 weeks)
Performance status: before treatment (each 3 weeks)
Haematology: before treatment (each 3 weeks)
Tumor biology: after 1st treatment, every 9th weeks herafter
Biochemistry: after every 3rd treatment (each 9th weeks)
Tumor assesment: after every 3rd treatment (each 9th weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for C04.588.274.476.411.307Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Pfeiffer, Odense University Hospital
- Investigators
- Per Pfeiffer, MD, Principal investigator, Department of Oncology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212615
- Sponsor's protocol ID
- XELOX III
- Other IDs
- KFE 03.17
- Status last verified
- Nov 2020
- First submitted
- 13 Sep 2005
- Last updated
- 6 Nov 2020
- Results posted
- No
Publications
Pfeiffer P, Hahn P, Jensen HA. Short-time infusion of oxaliplatin (Eloxatin) in combination with capecitabine (Xeloda) in patients with advanced colorectal cancer. Acta Oncol. 2003;42(8):832-6. doi: 10.1080/02841860310015894.
PubMed 14968944Boisen MK, Johansen JS, Dehlendorff C, Larsen JS, Osterlind K, Hansen J, Nielsen SE, Pfeiffer P, Tarpgaard LS, Hollander NH, Keldsen N, Hansen TF, Jensen BB, Jensen BV. Primary tumor location and bevacizumab effectiveness in patients with metastatic colorectal cancer. Ann Oncol. 2013 Oct;24(10):2554-2559. doi: 10.1093/annonc/mdt253. Epub 2013 Jul 17.
PubMed 23864097
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT00212615
- Acronym / sponsor ID
- XELOX III
- Conditions
- C04.588.274.476.411.307
- Keywords
- Colorectal neoplasm, Capecitabine (Xeloda), Oxaliplatin (Eloxatin), Advanced disease, Metastatic disease, First-line treatment, Phase II study
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Feb 2004 (actual)
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 Sep 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.
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).
Bloodsamples will be collected and frozen and later examined for potential predictive factors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Oxaliplatin (Eloxatin), Drug: Capecitabine (Xeloda)Standard XELOX |
| B | Active comparator | Drug: Oxaliplatin (Eloxatin), Drug: Capecitabine (Xeloda)Chronomodulated XELOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological proven adenocarcinoma of the colon or rectum
- Measurable or non-measurable disease
- Performance status 0-2
- Adequate renal and hepatic functions
- Adjuvant chemotherapy must have ended 180 days before inclusion
Key exclusion criteria (8 listed)
- Prior treatment with Eloxatin or Xeloda
- Peripheral neuropathy
- Evidence of CNS metastasis
- Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months)
- Past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer
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 (Eloxatin) | Drug | A, B |
| Capecitabine (Xeloda) | Drug | A, B |
Primary outcome
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
6 secondary outcomes
Physical examination: before treatment (each 3 weeks)
Performance status: before treatment (each 3 weeks)
Haematology: before treatment (each 3 weeks)
Tumor biology: after 1st treatment, every 9th weeks herafter
Biochemistry: after every 3rd treatment (each 9th weeks)
Tumor assesment: after every 3rd treatment (each 9th weeks)
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 6 Nov 2020.
- Background: PubMed 14968944Pfeiffer P, Hahn P, Jensen HA. Short-time infusion of oxaliplatin (Eloxatin) in combination with capecitabine (Xeloda) in patients with advanced colorectal cancer. Acta Oncol. 2003;42(8):832-6. doi: 10.1080/02841860310015894.
- Derived from this study: PubMed 23864097Boisen MK, Johansen JS, Dehlendorff C, Larsen JS, Osterlind K, Hansen J, Nielsen SE, Pfeiffer P, Tarpgaard LS, Hollander NH, Keldsen N, Hansen TF, Jensen BB, Jensen BV. Primary tumor location and bevacizumab effectiveness in patients with metastatic colorectal cancer. Ann Oncol. 2013 Oct;24(10):2554-2559. doi: 10.1093/annonc/mdt253. Epub 2013 Jul 17.
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.
Per Pfeiffer, MD principal investigator
Department of Oncology, Odense University Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxaliplatin (Eloxatin) and Capecitabine (Xeloda) in people with C04.588.274.476.411.307, run by Odense University Hospital at 8 sites in 2 countries.
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 6 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 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark, Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212615, which also lists 2 linked publications.
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 6 Nov 2020.