Metastatic Colorectal CancerPhase 2NCT00345696
1stline Study Capecitabine Administered on Continuous Way Plus Oxaliplatin&Bevacizumab Every 2weeks in Metastatic CCR.
A Phase 2 study testing Bevacizumab, Capecitabine and Oxaliplatine in people with Metastatic Colorectal Cancer, run by Unidad Integral de Investigación en Oncología S.L. at 1 site in Spain.
Trial summary
The purpose of this study is to determinate progression free survival after 9 months of treatment. 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, Capecitabine and Oxaliplatine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2006to Jan 2011
- 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
- Men and women > or = 18 years
- Outpatients with ECOG performance status ≤ 2.
- Histologically confirmed diagnosis of CRC patients with metastasis.
- Presence of at least one detectable lesion in accordance with RECIST criteria.
- Life expectancy greater than 3 months.
- Patients who are able to understand the study request and want to participate.
- Written informed consent given
Who cannot join
- Patients who have been treated with Bevacizumab previously.
- Received any systemic treatment previously to treat an advanced or metastatic disease
- Adjuvant or neoadjuvant treatment to non-metastatic disease is allowed, provided that there has been finished at least 6 months before the initial study treatment.
- If the patient has been treated with adjuvant therapy previously, it is not allowed to be included in the study in case of disease progression during the treatment or during 6 months later than the end of the treatment.
- If radiotherapy has been administered it has not been administered in the lesion selected for the study, and the end of the treatment has been finished at least 4 weeks before the study initiation.
- Previous surgical procedure of the IV stage disease is allowed.
Show all 24Show fewer
- PAst or current history (within the last 5 years) of malignancies except curatively treated basal and squamous cell carcinoma of the skin, and in-situ carcinoma of the cervix.
- History or evidence upon physical examination of central nervous system (CNS) (i.e. primary cerebral tumour, uncontrolled convulsions with standard medical treatment, cerebral metastasis or any kind or ictus history).
- History of psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
- Clinically significant cardiovascular disease (active), i.e, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication or peripheral vascular disease. Patients have undergone myocardial infarction in the previous year of the study initiation will be excluded.
- Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medications
- Patients subjected to allogenic transplant and request immunotherapy.
- Bone fracture not healed, wounds or severe ulcers.
- Known hemorrhagic diathesis or coagulopathy.
- Uncontrolled and severe intercurrent infections or another severe and uncontrolled concomitant diseases.
- Moderate or severe renal impairment (creatinine clearance < 30 ml/min (calculated according to Cockroft-Gault formula) or serum creatinine >1,5 x ULN.
- Any of the following laboratory values:
- Absolute neutrophils count (ANC) < 1.5 x 109/l. Platelet count < 100 x 109/l. Hemoglobin < 9 g/dl. INR > 1.5. Total bilirubin > 1.5 ULN. ALT and/or AST > 2.5 x ULN or > 5 x ULN (in case of hepatic metastasis). Alkaline phosphatase > 2.5 x ULN or >5 x ULN (in case of hepatic metastasis), or > 10 x ULN (in case of bone metastasis).
- History of unexpected serious adverse events to fluoropyrimidine treatments or known dihydropyrimidine dehydrogenase (DPD) deficiency.
- Patients subjected to major surgical procedure, open biopsy or who had significant traumatic injures in 28 days time before the start of the study treatment , or patients with a major surgery procedure planning during the study period. Fine needle aspiration biopsy 7 days before the study initiation.
- Use of full dose of oral or parenteral anticoagulants ( at least 10 days before the start of the study treatment or thrombolytic agents. Low dose of warfarin is allowed, with an INR ≤ 1.5.
- Subject requiring chronic use of high dose aspirin (> 325 m/day) or non-steroidal anti-inflammatory treatment.
- Participation in another treatment trial within 4 weeks of the study initiation.
- Pregnant (serum positive pregnancy test) or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of First Line Capecitabine Administered on Continuous Way Combined With Oxaliplatin and Bevacizumab Every Two Weeks in Metastatic Colorectal Cancer Patients.
The purpose of this study is to determinate progression free survival after 9 months of treatment.
Read the detailed description
To look for a new chemotherapy management to get less acute and chronic toxicity and/or an easier administration treatment line.
This study tries to demonstrate an alternative chemotherapy scheme,continuous polychemotherapy regimen with less dose with the added effect of the monoclonal antibody Bevacizumab.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Bevacizumab, Capecitabine, Oxaliplatine
- Keywords
- Capecitabine, Oxaliplatin, Bevacizumab, First line
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
5 mg/Kg intravenous, 90-60-30 minutes, every 2 weeks.
CapecitabineDrug
Also called Xeloda
600 mg/m2, orally, every 12 hours, continuous.
OxaliplatineDrug
Also called Eloxatin
85 mg/m2, intravenous, 2 hours infusion, every 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 9 months
Secondary outcomes (4)
Overall Response rate
Measured: 24 months
Overall survival
Measured: 24 months
Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab
Measured: 24 months
Resection rate of hepatic or pulmonary metastases
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2008
- Study completionJan 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidad Integral de Investigación en Oncología S.L.
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Cristina Grávalos, MD, Study chair, Unidad Integral de Investigación en Oncología S.L.Cristina Grávalos, MD, Principal investigator, Hospital 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345696
- Sponsor's protocol ID
- XELOXAVBISEMANAL
- Status last verified
- Aug 2011
- First submitted
- 27 Jun 2006
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of First Line Capecitabine Administered on Continuous Way Combined With Oxaliplatin and Bevacizumab Every Two Weeks in Metastatic Colorectal Cancer Patients.
- ClinicalTrials.gov ID
- NCT00345696
- Acronym / sponsor ID
- XELOXAVBISEMANAL
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Capecitabine, Oxaliplatin, Bevacizumab, First line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Unidad Integral de Investigación en Oncología S.L.University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jun 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Jun 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.
The purpose of this study is to determinate progression free survival after 9 months of treatment.
Detailed description
To look for a new chemotherapy management to get less acute and chronic toxicity and/or an easier administration treatment line.
This study tries to demonstrate an alternative chemotherapy scheme,continuous polychemotherapy regimen with less dose with the added effect of the monoclonal antibody Bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women > or = 18 years
- Outpatients with ECOG performance status ≤ 2.
- Histologically confirmed diagnosis of CRC patients with metastasis.
- Presence of at least one detectable lesion in accordance with RECIST criteria.
- Life expectancy greater than 3 months.
Key exclusion criteria (24 listed)
- Patients who have been treated with Bevacizumab previously.
- Received any systemic treatment previously to treat an advanced or metastatic disease
- Adjuvant or neoadjuvant treatment to non-metastatic disease is allowed, provided that there has been finished at least 6 months before the initial study treatment.
- If the patient has been treated with adjuvant therapy previously, it is not allowed to be included in the study in case of disease progression during the treatment or during 6 months later than the end of the treatment.
- If radiotherapy has been administered it has not been administered in the lesion selected for the study, and the end of the treatment has been finished at least 4 weeks before the study initiation.
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 |
|---|---|---|
| BevacizumabAlso: Avastin5 mg/Kg intravenous, 90-60-30 minutes, every 2 weeks. | Drug | – |
| CapecitabineAlso: Xeloda600 mg/m2, orally, every 12 hours, continuous. | Drug | – |
| OxaliplatineAlso: Eloxatin85 mg/m2, intravenous, 2 hours infusion, every 2 weeks | Drug | – |
Primary outcome
Progression Free Survival
Time frame: 9 months
4 secondary outcomes
Overall Response rate
Time frame: 24 months
Overall survival
Time frame: 24 months
Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab
Time frame: 24 months
Resection rate of hepatic or pulmonary metastases
Time frame: 24 months
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 24 Aug 2011.
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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.
Cristina Grávalos, MD study chair
Unidad Integral de Investigación en Oncología S.L.
Cristina Grávalos, MD principal investigator
Hospital 12 de Octubre
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, Capecitabine and Oxaliplatine in people with Metastatic Colorectal Cancer, run by Unidad Integral de Investigación en Oncología S.L. at 1 site in Spain.
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 7 inclusion and 24 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 24 Aug 2011. 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 Spain. 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?
Progression Free Survival (time frame: 9 months). 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 24 Aug 2011.