Colorectal CancerPhase 4NCT02582970
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum
A Phase 4 study testing 5-Fluorouracil, Bevacizumab and Irinotecan in people with Colorectal Cancer, run by Hoffmann-La Roche at 8 sites in Taiwan.
Trial summary
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. 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?
- 5-Fluorouracil, Bevacizumab and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesTaiwan
- Study dates
- May 2005to Apr 2008
- Phase
- Phase 4
- 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
- Previously untreated metastatic colon or rectal cancer
- Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment
Who cannot join
- Prior chemotherapy for metastatic colon or rectal cancer
- Planned radiotherapy for underlying disease
- Central nervous system metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start
- Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Study site
Chai Yi, 613
Study site
Kaohsiung City, 00833
Study site
Kaohsiung City, 807
Study site
Taichung, 404
Study site
Taichung, 407
Study site
Tainan, 704
Study site
Tainan, 710
Study site
Taipei, 104
About this study
Official title: An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
- Conditions
- Colorectal Cancer
- Being tested
- 5-Fluorouracil, Bevacizumab, Irinotecan, 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-FluorouracilDrug
Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.
BevacizumabDrug
Also called Avastin
Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.
IrinotecanDrug
Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.
OxaliplatinDrug
Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab + Chemotherapy | Experimental | Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study. Receives: Drug: 5-Fluorouracil; Drug: Bevacizumab; Drug: Irinotecan; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Measured: Baseline up to approximately 3 years
Secondary outcomes (6)
Percentage of Participants Who Died
Measured: Baseline up to approximately 3 years
Duration of Survival
Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis.
Measured: Baseline up to approximately 3 years
Percentage of Participants With Disease Progression or Death
Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).
Measured: Baseline up to approximately 3 years
Progression-Free Survival Time
Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis.
Measured: Baseline up to approximately 3 years
Number of Participants With Best Overall Response
The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.
Measured: Baseline up to approximately 3 years
Mean Direct Medical Cost for Cancer Related Medical Care Utilization
Direct medical cost included cost of out-patient consultation and cost of hospitalization.
Measured: Baseline up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startMay 2005
- Primary completionOct 2007
- Study completionApr 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582970
- Sponsor's protocol ID
- ML18436
- Status last verified
- Jan 2017
- First submitted
- 12 Oct 2015
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
- ClinicalTrials.gov ID
- NCT02582970
- Acronym / sponsor ID
- ML18436
- Conditions
- Colorectal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab + Chemotherapy | Experimental | Drug: 5-Fluorouracil, Drug: Bevacizumab, Drug: Irinotecan, Drug: OxaliplatinParticipants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previously untreated metastatic colon or rectal cancer
- Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment
Key exclusion criteria (5 listed)
- Prior chemotherapy for metastatic colon or rectal cancer
- Planned radiotherapy for underlying disease
- Central nervous system metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start
- Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment
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-FluorouracilIntravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor. | Drug | Bevacizumab + Chemotherapy |
| BevacizumabAlso: AvastinBevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study. | Drug | Bevacizumab + Chemotherapy |
| IrinotecanIrinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study. | Drug | Bevacizumab + Chemotherapy |
| OxaliplatinOxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study. | Drug | Bevacizumab + Chemotherapy |
Primary outcome
Percentage of Participants With Adverse Events
Time frame: Baseline up to approximately 3 years
An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.
6 secondary outcomes
Percentage of Participants Who Died
Time frame: Baseline up to approximately 3 years
Duration of Survival
Time frame: Baseline up to approximately 3 years
Percentage of Participants With Disease Progression or Death
Time frame: Baseline up to approximately 3 years
Progression-Free Survival Time
Time frame: Baseline up to approximately 3 years
Number of Participants With Best Overall Response
Time frame: Baseline up to approximately 3 years
Mean Direct Medical Cost for Cancer Related Medical Care Utilization
Time frame: Baseline up to approximately 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- 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 chair
Hoffmann-La Roche
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5-Fluorouracil, Bevacizumab and Irinotecan in people with Colorectal Cancer, run by Hoffmann-La Roche at 8 sites in Taiwan.
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 2 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Mar 2017). 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?
Percentage of Participants With Adverse Events (time frame: Baseline up to approximately 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 Mar 2017.