Colorectal CancerPhase 2NCT00940303
OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer
A Phase 2 study testing 5-FU, bevacizumab [Avastin] and irinotecan in people with Colorectal Cancer, run by Hoffmann-La Roche at 17 sites in Germany.
Trial summary
This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- 5-FU, bevacizumab [Avastin] and irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 17 sitesGermany
- Study dates
- Jun 2009to Feb 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-70 years of age;
- metastatic colorectal cancer scheduled for standard first line chemotherapy;
- at least 1 measurable lesion;
- ECOG performance score of 0 or 1.
Who cannot join
- prior chemotherapy for metastatic colorectal cancer;
- prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy completed within 6 months prior to study entry;
- concomitant malignancies other CRC;
- history or evidence of CNS disease unrelated to cancer.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Germany17 sites
Study site
Berlin, 10117
Study site
Berlin, 13347
Study site
Bochum, 44791
Study site
Celle, 29221
Study site
Celle, 29223
Study site
Dessau, 06847
Study site
Freiburg im Breisgau, 79106
Study site
Fulda, 36043
Study site
Hamburg, 20246
Study site
Hamburg, 22087
Study site
Hanover, 30171
Study site
Leer, 26789
Study site
Magdeburg, 39120
Study site
Magdeburg, 39130
Study site
Nuremberg, 90419
Study site
Stade, 21680
Study site
Villingen-Schwenningen, 78052
About this study
Official title: An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)
This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
- Conditions
- Colorectal Cancer
- Being tested
- 5-FU, bevacizumab [Avastin], irinotecan, leucovorin, 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.
5-FUDrug
3200mg/m2 continuous iv infusions, day 1 every 2 weeks
bevacizumab [Avastin]Drug
5mg/kg iv infusion, day 1 every 2 weeks
irinotecanDrug
165mg/m2 iv infusion, day 1 every 2 weeks
leucovorinDrug
200mg/m2 iv infusion, day 1 every 2 weeks
oxaliplatinDrug
85mg/m2 iv infusion, day 1 every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: 5-FU; Drug: bevacizumab [Avastin]; Drug: irinotecan; Drug: leucovorin; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: assessed every 8 weeks up to week 102, 3-monthly during follow-up
Secondary outcomes (2)
Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy.
Measured: assessed every 4 weeks up to week 102 and at the end of follow-up period
Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.
Measured: Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2014
- Study completionFeb 2014
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 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
- Single group
- Masking
- None (open label)
- Enrolment
- 97 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
- NCT00940303
- Sponsor's protocol ID
- ML20514
- Other IDs
- 2008-001180-11, 2008
- Status last verified
- Nov 2016
- First submitted
- 6 Jul 2009
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Stein A, Atanackovic D, Hildebrandt B, Stubs P, Brugger W, Hapke G, Steffens CC, Illerhaus G, Bluemner E, Stohlmacher J, Bokemeyer C. Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer. Br J Cancer. 2015 Sep 15;113(6):872-7. doi: 10.1038/bjc.2015.299. Epub 2015 Sep 3.
PubMed 26335608
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)
- ClinicalTrials.gov ID
- NCT00940303
- Acronym / sponsor ID
- ML20514
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Jul 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 single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. 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
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 5-FU, Drug: bevacizumab [Avastin], Drug: irinotecan, Drug: leucovorin, Drug: oxaliplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, 18-70 years of age;
- metastatic colorectal cancer scheduled for standard first line chemotherapy;
- at least 1 measurable lesion;
- ECOG performance score of 0 or 1.
Key exclusion criteria (4 listed)
- prior chemotherapy for metastatic colorectal cancer;
- prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy completed within 6 months prior to study entry;
- concomitant malignancies other CRC;
- history or evidence of CNS disease unrelated to cancer.
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 |
|---|---|---|
| 5-FU3200mg/m2 continuous iv infusions, day 1 every 2 weeks | Drug | 1 |
| bevacizumab [Avastin]5mg/kg iv infusion, day 1 every 2 weeks | Drug | 1 |
| irinotecan165mg/m2 iv infusion, day 1 every 2 weeks | Drug | 1 |
| leucovorin200mg/m2 iv infusion, day 1 every 2 weeks | Drug | 1 |
| oxaliplatin85mg/m2 iv infusion, day 1 every 2 weeks | Drug | 1 |
Primary outcome
Progression-free survival
Time frame: assessed every 8 weeks up to week 102, 3-monthly during follow-up
2 secondary outcomes
Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy.
Time frame: assessed every 4 weeks up to week 102 and at the end of follow-up period
Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.
Time frame: Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks
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 2 Nov 2016.
- Derived from this study: PubMed 26335608Stein A, Atanackovic D, Hildebrandt B, Stubs P, Brugger W, Hapke G, Steffens CC, Illerhaus G, Bluemner E, Stohlmacher J, Bokemeyer C. Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer. Br J Cancer. 2015 Sep 15;113(6):872-7. doi: 10.1038/bjc.2015.299. Epub 2015 Sep 3.
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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
17 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 5-FU, bevacizumab [Avastin] and irinotecan in people with Colorectal Cancer, run by Hoffmann-La Roche at 17 sites in Germany.
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 4 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany. 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: assessed every 8 weeks up to week 102, 3-monthly during follow-up). 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 NCT00940303, 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 2 Nov 2016.