Metastatic Colorectal CancerPhase 2NCT01024504
Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Oxaliplatin, Capecitabine and Bevacizumab in people with Metastatic Colorectal Cancer, run by Hellenic Oncology Research Group at 6 sites in Greece.
Trial summary
This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Oxaliplatin, Capecitabine and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesGreece
- Study dates
- Mar 2006to Mar 2010
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- Stage IV
- Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
- Absence or irradiated and stable central nervous system metastatic disease.
- Life expectancy of more than 3 months.
- Age ≥ 70 years.
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- Performance status (WHO) ≤ 2.
- Adequate bone marrow function (Absolute neutrophil count >1000/mm3, Platelet count >100000/mm3, Hemoglobin >9gr/mm3).
- Adequate liver (Bilirubin <1.5 times upper limit of normal and SGOT/SGPT <2 times upper limit of normal).
- Creatinine clearance (Cockcroft-Gault formula) >30ml/min.
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
- Presence of a reliable care giver.
- Informed consent.
Who cannot join
- Prior chemotherapy for metastatic disease.
- History of thromboembolic disease or myocardial infraction within the last 6 months.
- Peripheral neuropathy ≥ grade 2.
- Bowel obstruction or chronic diarrhea.
- Psychiatric illness or social situation that would preclude study compliance.
- Other concurrent uncontrolled illness.
- Other concurrent investigational agents.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Greece6 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
Air Forces Military Hospital of Athens
Athens
IASO General Hospital of Athens, 1st Dep of Medical Oncology
Athens
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
State General Hospital of Larissa
Larissa
Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
About this study
Official title: A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.
Read the detailed description
Capecitabine, oxaliplatin and bevacizumab are well known active agents in the treatment of mCRC. The treatment of elderly patients with mCRC is an area of investigation. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Oxaliplatin, Capecitabine, Bevacizumab
- Keywords
- Cancer, Colorectal cancer, Elderly, Chemotherapy, Capecitabine, Oxaliplatin, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called Eloxatin
Oxaliplatin at the dose of 85 mg/m2 over a 4 hour intravenous infusion at day 1 every 2 weeks for a maximum of 12 consecutive cycles
CapecitabineDrug
Also called Xeloda
Capecitabine at the dose of 1500 mg/m2 per os at days 1 to 7 every 2 weeks for a maximum of 12 consecutive cycles
BevacizumabDrug
Also called Avastin
Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles
| Study group | Role | What they receive |
|---|---|---|
| XELOX/Avastin | Experimental | Capecitabine Oxaliplatin Bevacizumab Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 2 - 4 months
Secondary outcomes (3)
Toxicity profile
Measured: Toxicity assessment on each cycle
Time to tumor progression
Measured: 1 year
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startMar 2006
- Primary completionMar 2010
- Study completionMar 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- John Souglakos, MD, Principal investigator, University Hospital of Crete, Dep of Medical OncologyLampros Vamvakas, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024504
- Sponsor's protocol ID
- CT/06.12
- Status last verified
- Apr 2010
- First submitted
- 26 Nov 2009
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Vamvakas L, Matikas A, Karampeazis A, Hatzidaki D, Kakolyris S, Christophylakis C, Boukovinas I, Polyzos A, Georgoulias V, Souglakos J. Capecitabine in combination with oxaliplatin and bevacizumab (AXELOX) as 1st line treatment for fit and vulnerable elderly patients (aged >70 years) with metastatic colorectal cancer (mCRC): a multicenter phase II study of the Hellenic Oncology Research Group (HORG). BMC Cancer. 2014 Apr 22;14:277. doi: 10.1186/1471-2407-14-277.
PubMed 24755296
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01024504
- Acronym / sponsor ID
- CT/06.12
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Cancer, Colorectal cancer, Elderly, Chemotherapy, Capecitabine, Oxaliplatin, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Mar 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Dec 2009 (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.
This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.
Detailed description
Capecitabine, oxaliplatin and bevacizumab are well known active agents in the treatment of mCRC. The treatment of elderly patients with mCRC is an area of investigation. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XELOX/Avastin | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: BevacizumabCapecitabine Oxaliplatin Bevacizumab |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- Stage IV
- Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
- Absence or irradiated and stable central nervous system metastatic disease.
- Life expectancy of more than 3 months.
Key exclusion criteria (7 listed)
- Prior chemotherapy for metastatic disease.
- History of thromboembolic disease or myocardial infraction within the last 6 months.
- Peripheral neuropathy ≥ grade 2.
- Bowel obstruction or chronic diarrhea.
- Psychiatric illness or social situation that would preclude study compliance.
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: EloxatinOxaliplatin at the dose of 85 mg/m2 over a 4 hour intravenous infusion at day 1 every 2 weeks for a maximum of 12 consecutive cycles | Drug | XELOX/Avastin |
| CapecitabineAlso: XelodaCapecitabine at the dose of 1500 mg/m2 per os at days 1 to 7 every 2 weeks for a maximum of 12 consecutive cycles | Drug | XELOX/Avastin |
| BevacizumabAlso: AvastinBevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles | Drug | XELOX/Avastin |
Primary outcome
Overall response rate
Time frame: 2 - 4 months
3 secondary outcomes
Toxicity profile
Time frame: Toxicity assessment on each cycle
Time to tumor progression
Time frame: 1 year
Overall survival
Time frame: 1 year
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 9 Apr 2010.
- Derived from this study: PubMed 24755296Vamvakas L, Matikas A, Karampeazis A, Hatzidaki D, Kakolyris S, Christophylakis C, Boukovinas I, Polyzos A, Georgoulias V, Souglakos J. Capecitabine in combination with oxaliplatin and bevacizumab (AXELOX) as 1st line treatment for fit and vulnerable elderly patients (aged >70 years) with metastatic colorectal cancer (mCRC): a multicenter phase II study of the Hellenic Oncology Research Group (HORG). BMC Cancer. 2014 Apr 22;14:277. doi: 10.1186/1471-2407-14-277.
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CRC
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.
John Souglakos, MD principal investigator
University Hospital of Crete, Dep of Medical Oncology
Lampros Vamvakas, MD principal investigator
University Hospital of Crete
6 sites 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, Capecitabine and Bevacizumab in people with Metastatic Colorectal Cancer, run by Hellenic Oncology Research Group at 6 sites in Greece.
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 13 inclusion and 7 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 9 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece. 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?
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?
Overall response rate (time frame: 2 - 4 months). 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 NCT01024504, 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 9 Apr 2010.