Metastatic Colorectal CancerPhase 2BECOXNCT01067053
Efficacy/Safety Study of Bevacizumab,Capecitabine,Oxaliplatin to Metastatic Colorectal Adenocarcinoma Elderly Patients.
A Phase 2 study testing bevacizumab, capecitabine, oxaliplatin in people with Metastatic Colorectal Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 15 sites in Spain.
Trial summary
The purpose of this study is to determine whether bevacizumab, capecitabine and oxaliplatin are an effective and safe first line of treatment for elderly patients with metastatic colorectal adenocarcinoma. 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?
- bevacizumab, capecitabine, oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 15 sitesSpain
- Study dates
- Nov 2009to Mar 2014
- 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
- Written informed consent.
- ECOG 0-1.
- Age ≥ 70 years.
- Histologically confirmed carcinoma of the colon and/or rectum.
- Metastatic disease non suitable for radical surgery.
- At least one measurable metastatic lesion (as per RECIST criteria). The index lesion must not be in a previously irradiated area.
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- Non prior chemotherapy for metastatic disease. Adjuvant (or neo-adjuvant for rectal cancer patients) chemotherapy allowed if completed ≥ 12 months before inclusion.
- Life expectancy more than 3 months.
- Adequate renal function: creatinine ≤ 1.5 x UL and calculated creatinine clearance ≥ 30 mL/min.
- Adequate level function: AST and ALT ≤ 2.5 x UL (≤ 5 x UL if liver metastases), bilirubin ≤ 1.5 x UL.
- Adequate haematological function: Hb ≥ 9 gr/dl, neutrophils ≥ 1,5 x 109 /l and platelets ≥ 100000 x 109/l.
- Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.
- No clinical evidence or history of metastatic CNS disease.
- No prior Bevacizumab treatment.
Who cannot join
- Patients who previously received bevacizumab.
- Prior chemotherapeutic treatment for metastatic CRC.
- Prior treatment with monoclonal antibodies.
- Clinical evidence of brain metastases or history or evidence upon physical examination of CNS disease unless adequately treated.
- Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
- Clinically significant cardiovascular disease, for example CVA (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2, CHF, arrhythmia requiring medication, or uncontrolled hypertension.
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- Intestinal occlusion/subocclusion.
- Chronic diarrhea.
- Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
- Known hypersensitivity to any of the study drugs.
- Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (> 325 mg/day) or other NSAID.
- Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes. Patients receiving (or considered candidate to receive) anticoagulants agents as prophylaxis of cardiovascular risk, should continue (or start) the appropriate treatment at study entry.
- History of venous thromboembolic or haemorrhagic events within 6 months prior to treatment.
- Patients with previous of arterial thromboembolic event.
- Evidence of bleeding diathesis or coagulopathy.
- Serious, non healing wound, ulcer, or bone fracture.
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study.
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
- Patients of childbearing potential not willing to use effective means of contraception.
- Positive HIV serology.
- Known addiction to alcohol or other drugs.
- Patients included in other clinical trial
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital Clinic i Provincial
Barcelona, Barcelona, 08036
Hospital General Yagüe
Burgos, Burgos, 09005
Hospital de L´Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08906
Hospital de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Las Palmas, 35010
Hospital Arnau de Vilanova
Lleida, Lérida, 25198
Hospital Universitario la Paz
Madrid, Madrid, 28046
Hospital Quirón de Madrid
Madrid, Madrid, 28223
Hospital Morales Meseguer
Murcia, Murcia, 30008
Hospital de Navarra
Pamplona, Navarre, 31008
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702
Hospital La Fe de Valencia
Valencia, Valencia, 46009
Hospital General de Valencia
Valencia, Valencia, 46014
Hospital Doctor Peset
Valencia, Valencia, 46017
Hospital Xeral Cies de Vigo
Vigo, Vigo, 36204
Hospital Lluis Alcanyis
Xàtiva, Valencia, 46800
About this study
Official title: A Non Randomized Phase II Trial to Assess Efficacy and Safety of Bevacizumab, Capecitabine and Oxaliplatin as First Line Treatment for Elderly Patients With Metastatic Colorectal Adenocarcinoma, Suitable for Polychemotherapy Treatment
The purpose of this study is to determine whether bevacizumab, capecitabine and oxaliplatin are an effective and safe first line of treatment for elderly patients with metastatic colorectal adenocarcinoma.
Read the detailed description
The efficacy will be determined by objective response rate following RECIST criteria.
In several clinical trials with Bevacizumab, there has been demonstrated that elderly patients benefits as well as the younger of a combination therapy with chemotherapy plus Bevacizumab, but these results have come from subgroup analyses of trials not specifically design to test the effect of these combinations on the elderly. This clinical trial is specific only for elderly patients and we expect to confirm the benefits demonstrated in other clinical trials where the elderly patients were a number reduced.
This clinical trial includes 3 substudies:
- Assessment of tumor response of CRC liver metastases to treatment with Avastin in combination with Capecitabine and Oxaliplatin as first line treatment by dynamic ultrasound contrast.
Main objective: Assess the performance of dynamic contrast ultrasonography (CEUS, Contrast Enhanced UltraSound) with quantification of tumor perfusion in the evaluation of tumor response of liver metastases of colorectal carcinoma to treatment with Avastin in combination with Capecitabine and Oxaliplatin.
-Evaluation of the antiangiogenic activity of bevacizumab combined with oxaliplatin and capecitabine in first line treatment using MDCT perfusion studies in liver metastases of colorectal cancer in patients over 70 years.
Main objective:Determine whether the observed changes in perfusion CT studies performed at 2 weeks of starting treatment compared to baseline are significant predictors of free time to disease progression in patients in the trial and defined as the time since the start of treatment until objective progressive disease by RECIST criteria.
-Characterization of resistance to bevacizumab in colon cancer in elderly patients.
Main objective: To evaluate the involvement of serum markers and markers in the primary tumor in the resistance to bevacizumab.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- bevacizumab, capecitabine, oxaliplatin
- Keywords
- Bevacizumab, Capecitabine, Oxaliplatin, 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, capecitabine, oxaliplatinDrug
Also called bevacizumab (Avastin®), capecitabine (Xeloda®), oxaliplatin
6 cycles (3 weeks each one) of:
- bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle.
- capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks.
- oxaliplatin: 130/mg/m2(iv),1st day of each cycle.
After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab, capecitabine, oxaliplatin | Experimental | 6 cycles (3 weeks each one) of:
* bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle.
* capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks.
* oxaliplatin: 130/mg/m2(iv),1st day of each cycle.
After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine Receives: Drug: bevacizumab, capecitabine, oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Measured: 3 years
Secondary outcomes (6)
Overall survival
Measured: 3 years
Objective response rate following Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Measured: 3 years
Overall response rate
Measured: 3 years
Number of treatment cycles administered
Measured: 3 years
Number of patients who have required dose reductions of either drug
Measured: 3 years
Safety of treatment according to the number of adverse events reported
Measured: 3 yeras
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionMar 2014 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaime Feliu Batlle, MD, Study chair, Grupo Español Multidisciplinario de Cáncer Digestivo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067053
- Sponsor's protocol ID
- GEMCAD-0901
- Acronym
- BECOX
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2010
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non Randomized Phase II Trial to Assess Efficacy and Safety of Bevacizumab, Capecitabine and Oxaliplatin as First Line Treatment for Elderly Patients With Metastatic Colorectal Adenocarcinoma, Suitable for Polychemotherapy Treatment
- ClinicalTrials.gov ID
- NCT01067053
- Acronym / sponsor ID
- BECOX / GEMCAD-0901
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Bevacizumab, Capecitabine, Oxaliplatin, Metastatic colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer DigestivoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Mar 2014 (estimated)
- First posted
- 11 Feb 2010 (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 determine whether bevacizumab, capecitabine and oxaliplatin are an effective and safe first line of treatment for elderly patients with metastatic colorectal adenocarcinoma.
Detailed description
The efficacy will be determined by objective response rate following RECIST criteria.
In several clinical trials with Bevacizumab, there has been demonstrated that elderly patients benefits as well as the younger of a combination therapy with chemotherapy plus Bevacizumab, but these results have come from subgroup analyses of trials not specifically design to test the effect of these combinations on the elderly. This clinical trial is specific only for elderly patients and we expect to confirm the benefits demonstrated in other clinical trials where the elderly patients were a number reduced.
This clinical trial includes 3 substudies:
- Assessment of tumor response of CRC liver metastases to treatment with Avastin in combination with Capecitabine and Oxaliplatin as first line treatment by dynamic ultrasound contrast.
Main objective: Assess the performance of dynamic contrast ultrasonography (CEUS, Contrast Enhanced UltraSound) with quantification of tumor perfusion in the evaluation of tumor response of liver metastases of colorectal carcinoma to treatment with Avastin in combination with Capecitabine and Oxaliplatin.
-Evaluation of the antiangiogenic activity of bevacizumab combined with oxaliplatin and capecitabine in first line treatment using MDCT perfusion studies in liver metastases of colorectal cancer in patients over 70 years.
Main objective:Determine whether the observed changes in perfusion CT studies performed at 2 weeks of starting treatment compared to baseline are significant predictors of free time to disease progression in patients in the trial and defined as the time since the start of treatment until objective progressive disease by RECIST criteria.
-Characterization of resistance to bevacizumab in colon cancer in elderly patients.
Main objective: To evaluate the involvement of serum markers and markers in the primary tumor in the resistance to bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab, capecitabine, oxaliplatin | Experimental | Drug: bevacizumab, capecitabine, oxaliplatin6 cycles (3 weeks each one) of: * bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle. * capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks. * oxaliplatin: 130/mg/m2(iv),1st day of each cycle. After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Written informed consent.
- ECOG 0-1.
- Age ≥ 70 years.
- Histologically confirmed carcinoma of the colon and/or rectum.
- Metastatic disease non suitable for radical surgery.
Key exclusion criteria (22 listed)
- Patients who previously received bevacizumab.
- Prior chemotherapeutic treatment for metastatic CRC.
- Prior treatment with monoclonal antibodies.
- Clinical evidence of brain metastases or history or evidence upon physical examination of CNS disease unless adequately treated.
- Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
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, capecitabine, oxaliplatinAlso: bevacizumab (Avastin®), capecitabine (Xeloda®), oxaliplatin6 cycles (3 weeks each one) of: * bevacizumab: 7,5 mg/kg (iv), 1st day of each cycle. * capecitabine: 1000 mg/m2 bid, oral. Days: 1-14 every three weeks. * oxaliplatin: 130/mg/m2(iv),1st day of each cycle. After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine | Drug | bevacizumab, capecitabine, oxaliplatin |
Primary outcome
Time to progression
Time frame: 3 years
6 secondary outcomes
Overall survival
Time frame: 3 years
Objective response rate following Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Time frame: 3 years
Overall response rate
Time frame: 3 years
Number of treatment cycles administered
Time frame: 3 years
Number of patients who have required dose reductions of either drug
Time frame: 3 years
Safety of treatment according to the number of adverse events reported
Time frame: 3 yeras
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
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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.
Jaime Feliu Batlle, MD study chair
Grupo Español Multidisciplinario de Cáncer Digestivo
15 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 bevacizumab, capecitabine, oxaliplatin in people with Metastatic Colorectal Cancer, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 15 sites 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 14 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
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?
Time to progression (time frame: 3 years). 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 9 Jan 2014.