Metastatic Colorectal CancerPhase 2AXOAXINCT01531595
Study of Bevacizumab in Combination with Alternating XELIRI and XELOX in Metastatic Colorectal Cancer
A Phase 2 study testing Bevacizumab plus alternating XELOX/XELIRI in people with Metastatic Colorectal Cancer, run by Pia Osterlund at 1 site in Finland.
Trial summary
Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with alternating XELIRI (capecitabine+irinotecan) and XELOX (capecitabine+oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Bevacizumab plus alternating XELOX/XELIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2012to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Patients with histologically confirmed diagnosis of colorectal cancer (CRC), chemotherapy naïve for metastatic disease (prior adjuvant chemotherapy more than 6 months previously for CRC allowed), who are scheduled to start first line chemotherapy for metastatic disease
- Age > 18
- Measurable or evaluable metastatic disease
- Performance status Eastern co-operative oncology group (ECOG) performance status 0-2
- Life expectancy greater than 3 months
- Normal Thrombocytes, neutrophils, Aspartate amino transferase/Alanine amino transferase, Alkaline phosphatase, Serum bilirubin, Serum Creatinine, Urine dipstick of proteinuria.
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- Women of childbearing potential must have a negative serum pregnancy test done prior to the administration of bevacizumab. Patient and their partner should have adequate contraception up to at least 6 months after last treatment completion or the last drug dose, whatever happens first
- Signed written informed consent according to international council for harmonization (ICH)/Good clinical practice (GCP) and the local regulations (approved by the Independent Ethics Committee (IEC)) will be obtained prior to any study specific screening procedures
- Patient must be able to comply with the protocol
Who cannot join
- Prior treatment with first-line chemotherapy for metastatic CRC
- Adjuvant treatment within 6 months
- Major surgical procedure (placing of central venous access device and liver biopsy etc are considered minor procedure), open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery)
- Near future planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed)
- Clinical or radiological evidence of central nervous system (CNS) metastases
- Past or current history within the last 2 years of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in-situ carcinoma of the cervix
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- Serious non-healing wound or ulcer
- Evidence of bleeding diathesis or coagulopathy
- Uncontrolled hypertension
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- Treatment with any investigational drug within 30 days prior to enrolment
- Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the treatment or patient at high risk from treatment complications
- Chronic daily intake of aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day)
- Pregnancy (positive serum pregnancy test) and lactation
- Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Bevacizumab in Combination with Alternating XELIRI and XELOX As First-line Treatment of Patients with Metastatic Colorectal Cancer
- Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with alternating XELIRI (capecitabine+irinotecan) and XELOX (capecitabine+oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.
- Primary objective: Progression Free Survival (PFS),
- To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection.
- Secondary objectives: To assess response rates according to RECIST criteria, failure free survival (TTF) and overall survival (OS), Quality of life according to 15-dimensional instrument (15D) questionnaire, To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria, Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms that may predict drug effects, safety, resectability and clinical behaviour of the tumour
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Bevacizumab plus alternating XELOX/XELIRI
- Keywords
- metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab plus alternating XELOX/XELIRIDrug
Also called Avastin (bevacizumab), Xeloda (capecitabine), irinotecan, oxaliplatin
3 cycles of XELOX+bevacizumab alternating with 3 cycles XELIRI+bevacizumab until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy plus bevacizumab | Experimental | Bevacizumab plus alternating XELOX x3 cycles (capecitabine + oxaliplatin) and XELIRI x3 cycles (capecitabine + irinotecan) Receives: Drug: Bevacizumab plus alternating XELOX/XELIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability of metastases
To evaluate technical resectability rate of colorectal cancer metastasis after conversion therapy
Measured: 5 years
Efficacy of alternating therapy
Progression free survival rate at 12 months
Measured: 5 years
Secondary outcomes (4)
Response of alternating therapy
To assess response rates according to RECIST criteria
Measured: 5 years
Efficacy of treatment
Overall survival
Measured: 5 years
Progression-free survival
Progression-free survival
Measured: 5 years
Translational research
Prognostic and predictive factors
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pia Osterlund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pia Osterlund, Helsinki University Central Hospital
- Investigators
- Pia Osterlund, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531595
- Sponsor's protocol ID
- 2011-003137-33
- Acronym
- AXOAXI
- Status last verified
- Dec 2024
- First submitted
- 3 Feb 2012
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Osterlund E, Ristimaki A, Makinen MJ, Kytola S, Kononen J, Pfeiffer P, Soveri LM, Keinanen M, Sorbye H, Nunes L, Salminen T, Nieminen L, Uutela A, Halonen P, Algars A, Sundstrom J, Kallio R, Ristamaki R, Lamminmaki A, Stedt H, Heerva E, Kuopio T, Sjoblom T, Isoniemi H, Glimelius B, Osterlund P. Atypical (non-V600E) BRAF mutations in metastatic colorectal cancer in population and real-world cohorts. Int J Cancer. 2024 Feb 1;154(3):488-503. doi: 10.1002/ijc.34733. Epub 2023 Sep 19.
PubMed 37724848
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Bevacizumab in Combination with Alternating XELIRI and XELOX As First-line Treatment of Patients with Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01531595
- Acronym / sponsor ID
- AXOAXI / 2011-003137-33
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pia OsterlundUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Feb 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.
- Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with alternating XELIRI (capecitabine+irinotecan) and XELOX (capecitabine+oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.
- Primary objective: Progression Free Survival (PFS),
- To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection.
- Secondary objectives: To assess response rates according to RECIST criteria, failure free survival (TTF) and overall survival (OS), Quality of life according to 15-dimensional instrument (15D) questionnaire, To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria, Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms that may predict drug effects, safety, resectability and clinical behaviour of the tumour
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy plus bevacizumab | Experimental | Drug: Bevacizumab plus alternating XELOX/XELIRIBevacizumab plus alternating XELOX x3 cycles (capecitabine + oxaliplatin) and XELIRI x3 cycles (capecitabine + irinotecan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically confirmed diagnosis of colorectal cancer (CRC), chemotherapy naïve for metastatic disease (prior adjuvant chemotherapy more than 6 months previously for CRC allowed), who are scheduled to start first line chemotherapy for metastatic disease
- Age > 18
- Measurable or evaluable metastatic disease
- Performance status Eastern co-operative oncology group (ECOG) performance status 0-2
- Life expectancy greater than 3 months
Key exclusion criteria (15 listed)
- Prior treatment with first-line chemotherapy for metastatic CRC
- Adjuvant treatment within 6 months
- Major surgical procedure (placing of central venous access device and liver biopsy etc are considered minor procedure), open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery)
- Near future planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed)
- Clinical or radiological evidence of central nervous system (CNS) metastases
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 |
|---|---|---|
| Bevacizumab plus alternating XELOX/XELIRIAlso: Avastin (bevacizumab), Xeloda (capecitabine), irinotecan, oxaliplatin3 cycles of XELOX+bevacizumab alternating with 3 cycles XELIRI+bevacizumab until disease progression | Drug | Chemotherapy plus bevacizumab |
Primary outcome
Resectability of metastases
Time frame: 5 years
To evaluate technical resectability rate of colorectal cancer metastasis after conversion therapy
Efficacy of alternating therapy
Time frame: 5 years
Progression free survival rate at 12 months
4 secondary outcomes
Response of alternating therapy
Time frame: 5 years
Efficacy of treatment
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Translational research
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 37724848Osterlund E, Ristimaki A, Makinen MJ, Kytola S, Kononen J, Pfeiffer P, Soveri LM, Keinanen M, Sorbye H, Nunes L, Salminen T, Nieminen L, Uutela A, Halonen P, Algars A, Sundstrom J, Kallio R, Ristamaki R, Lamminmaki A, Stedt H, Heerva E, Kuopio T, Sjoblom T, Isoniemi H, Glimelius B, Osterlund P. Atypical (non-V600E) BRAF mutations in metastatic colorectal cancer in population and real-world cohorts. Int J Cancer. 2024 Feb 1;154(3):488-503. doi: 10.1002/ijc.34733. Epub 2023 Sep 19.
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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.
Pia Osterlund, MD principal investigator
Helsinki University Central Hospital
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 Bevacizumab plus alternating XELOX/XELIRI in people with Metastatic Colorectal Cancer, run by Pia Osterlund at 1 site in Finland.
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 9 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2024. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Resectability of metastases (time frame: 5 years). 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?
On the ClinicalTrials.gov record for NCT01531595, which also lists 1 linked publication.
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 12 Dec 2024.