Colorectal CancerPhase 2NCT01077739
A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin
A Phase 2 study testing fluorouracil (5FU), leucovorin and bevacizumab [Avastin] in people with Colorectal Cancer, run by Hoffmann-La Roche at 28 sites in Belgium.
Trial summary
This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- fluorouracil (5FU), leucovorin and bevacizumab [Avastin]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 28 sitesBelgium
- Study dates
- Jul 2009to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- adult patients >/=18 years of age
- metastatic colorectal cancer
- at least 1 measurable lesion according to RECIST v. 1.1
- patients with disease progression with prior FOLFIRI + Avastin therapy who are not candidates for primary metastasectomy
- disease progression </= 8 weeks after last dose of Avastin
- ECOG </=2
- No more than 8 weeks between 1st-line treatment with FOLFIRI + Avastin and 2nd-line treatment with XELOX or FOLFOX + Avastin
Who cannot join
- disease progression > 8 weeks after last Avastin administration
- clinically significant cardiovascular disease
- CNS disease except for treated brain metastasis
- history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
- major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Belgium28 sites
Study site
Aalst, 9300
Study site
Arlon, 6700
Study site
Assebroek, 8310
Study site
Aye, 6900
Study site
Bonheiden, 2820
Study site
Brasschaat, 2930
Study site
Bruges, 8000
Study site
Brussels, 1020
Study site
Brussels, 1180
Study site
Brussels, 1200
Study site
Charleroi, 6000
Study site
Dendermonde, 9200
Study site
Edegem, 2650
Study site
Genk, 3600
Study site
Ghent, 9000
Study site
Hasselt, 3500
Study site
Kortrijk, 8500
Study site
Mechelen, 2800
Study site
Merksem, 2170
Study site
Mont-godinne, 5530
Study site
Montigny-le-Tilleul, 6110
Study site
Namur, 5000
Study site
Ostend, 8400
Study site
Sint-Niklaas, 9100
Study site
Tournai, 7500
Study site
Turnhout, 2300
Study site
Verviers, 4800
Study site
Wilrijk, 2610
About this study
Official title: A Single-arm Open-label Phase II Study: Treatment Beyond Progression by Adding Bevacizumab to XELOX or FOLFOX Chemotherapy in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination
This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda [capecitabine] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
- Conditions
- Colorectal Cancer
- Being tested
- fluorouracil (5FU), leucovorin, bevacizumab [Avastin], capecitabine [Xeloda], oxaliplatin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracil (5FU)Drug
standard FOLFOX regimen
leucovorinDrug
standard FOLFOX regimen
bevacizumab [Avastin]Drug
7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks
capecitabine [Xeloda]Drug
standard XELOX regimen
oxaliplatinDrug
standard XELOX or FOLFOX regimen
| Study group | Role | What they receive |
|---|---|---|
| Avastin (bevacizumab) + standard of care | Experimental | Not described Receives: Drug: fluorouracil (5FU); Drug: leucovorin; Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression
PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.
Measured: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Secondary outcomes (3)
PFS From the Start of First-Line Therapy
PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.
Measured: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)
Percentage of participants with an overall response of CR or PR according to RECIST criteria.
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Measured: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression
Pro-angiogenic cytokine concentrations of placental growth factor (PlGF), basic fibroblast growth factor (bFGF), and hepatocyte growth factor (HGF) in participant sera were measured and reported in units of picograms/milliliter (pg/mL). The geometric mean was calculated as exp10 (mean of log10 transformed concentration) and the standard deviation (SD) is SD of log10 transformed concentration.
Measured: Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077739
- Sponsor's protocol ID
- ML22519
- Other IDs
- 2009-012090-36, 2009
- Status last verified
- Dec 2014
- First submitted
- 26 Feb 2010
- Last updated
- 15 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Open-label Phase II Study: Treatment Beyond Progression by Adding Bevacizumab to XELOX or FOLFOX Chemotherapy in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination
- ClinicalTrials.gov ID
- NCT01077739
- Acronym / sponsor ID
- ML22519
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Mar 2010 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda [capecitabine] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin (bevacizumab) + standard of care | Experimental | Drug: fluorouracil (5FU), Drug: leucovorin, Drug: bevacizumab [Avastin], Drug: capecitabine [Xeloda], Drug: oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adult patients >/=18 years of age
- metastatic colorectal cancer
- at least 1 measurable lesion according to RECIST v. 1.1
- patients with disease progression with prior FOLFIRI + Avastin therapy who are not candidates for primary metastasectomy
- disease progression </= 8 weeks after last dose of Avastin
Key exclusion criteria (5 listed)
- disease progression > 8 weeks after last Avastin administration
- clinically significant cardiovascular disease
- CNS disease except for treated brain metastasis
- history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
- major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment
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 |
|---|---|---|
| fluorouracil (5FU)standard FOLFOX regimen | Drug | Avastin (bevacizumab) + standard of care |
| leucovorinstandard FOLFOX regimen | Drug | Avastin (bevacizumab) + standard of care |
| bevacizumab [Avastin]7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks | Drug | Avastin (bevacizumab) + standard of care |
| capecitabine [Xeloda]standard XELOX regimen | Drug | Avastin (bevacizumab) + standard of care |
| oxaliplatinstandard XELOX or FOLFOX regimen | Drug | Avastin (bevacizumab) + standard of care |
Primary outcome
Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression
Time frame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.
3 secondary outcomes
PFS From the Start of First-Line Therapy
Time frame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)
Time frame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression
Time frame: Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
28 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 fluorouracil (5FU), leucovorin and bevacizumab [Avastin] in people with Colorectal Cancer, run by Hoffmann-La Roche at 28 sites in Belgium.
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 5 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 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Belgium. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (PFS) From the Start of Treatment Beyond Progression (time frame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 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 15 Dec 2014.