Colorectal CancerPhase 2NCT00118755
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing capecitabine, Oxaliplatin and bevacizumab in people with Colorectal Cancer, run by Hoffmann-La Roche.
Trial summary
This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. 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?
- capecitabine, Oxaliplatin and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Apr 2009
- 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
- Metastatic or inoperable locally advanced colorectal cancer
- >=1 measurable target lesion
Who cannot join
- Previous systemic therapy for advanced or metastatic disease
- Previous treatment with bevacizumab
About this study
Official title: A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer
This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
- Conditions
- Colorectal Cancer
- Being tested
- capecitabine, Oxaliplatin, bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
850 mg/m^2 po bid on Days 1-14 of each 3-week cycle
OxaliplatinDrug
130 mg/m^2 IV on Day 1 of each 3-week cycle
bevacizumabDrug
7.5 mg/kg IV on Day 1 of each 3-week cycle
capecitabineDrug
1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle
OxaliplatinDrug
85 mg/m^2 IV on Day 1 of each 2-week cycle
bevacizumabDrug
5 mg/kg IV on Day 1 of each 2-week cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: capecitabine; Drug: Oxaliplatin; Drug: bevacizumab |
| 2 | Active comparator | Not described Receives: Drug: capecitabine; Drug: Oxaliplatin; Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Time to disease progression or death (through follow-up phase)
Secondary outcomes (3)
Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death, for any cause.
Measured: Time to death (through follow-up phase): Approximate Median of 718 days
Best Overall Clinical Response
Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered "responders"), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.
Measured: Through follow-up phase: Approximate Median of 318 days
Duration of Overall Clinical Response (CR or PR)
Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.
Measured: Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionApr 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118755
- Sponsor's protocol ID
- ML18491
- Status last verified
- Feb 2011
- First submitted
- 1 Jul 2005
- Last updated
- 3 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00118755
- Acronym / sponsor ID
- ML18491
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Apr 2009 (actual)
- First posted
- 12 Jul 2005 (estimated)
- Results
- Posted 3 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: capecitabine, Drug: Oxaliplatin, Drug: bevacizumab |
| 2 | Active comparator | Drug: capecitabine, Drug: Oxaliplatin, Drug: bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Metastatic or inoperable locally advanced colorectal cancer
- >=1 measurable target lesion
Key exclusion criteria (2 listed)
- Previous systemic therapy for advanced or metastatic disease
- Previous treatment with bevacizumab
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 |
|---|---|---|
| capecitabine850 mg/m^2 po bid on Days 1-14 of each 3-week cycle | Drug | 1 |
| Oxaliplatin130 mg/m^2 IV on Day 1 of each 3-week cycle | Drug | 1 |
| bevacizumab7.5 mg/kg IV on Day 1 of each 3-week cycle | Drug | 1 |
| capecitabine1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle | Drug | 2 |
| Oxaliplatin85 mg/m^2 IV on Day 1 of each 2-week cycle | Drug | 2 |
| bevacizumab5 mg/kg IV on Day 1 of each 2-week cycle | Drug | 2 |
Primary outcome
Progression-free Survival (PFS)
Time frame: Time to disease progression or death (through follow-up phase)
Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).
3 secondary outcomes
Overall Survival
Time frame: Time to death (through follow-up phase): Approximate Median of 718 days
Best Overall Clinical Response
Time frame: Through follow-up phase: Approximate Median of 318 days
Duration of Overall Clinical Response (CR or PR)
Time frame: Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine, Oxaliplatin and bevacizumab in people with Colorectal Cancer, run by Hoffmann-La Roche.
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 2 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 3 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 Mar 2011). 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) (time frame: Time to disease progression or death (through follow-up phase)). 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 3 Mar 2011.