Colorectal NeoplasmsPhase 2NCT00314353
Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon
A Phase 2 study testing Bevacizumab, Oxaliplatin and Capecitabine in people with Colorectal Neoplasms, run by NSABP Foundation Inc at 1 site in United States.
Trial summary
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Bevacizumab, Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2010
- 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
- Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
- Evidence of adequate organ function (such as liver, kidneys, etc.)
Who cannot join
- Diagnosis of anal cancer
- Patients who are candidates for surgery
- Patients who have received previous treatments
- Pregnant or lactating women
- History of chronic disease(s) or other serious medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
NSABP Operations Center
Pittsburgh, Pennsylvania, 15212
About this study
Official title: Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.
Read the detailed description
Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.
- Conditions
- Colorectal Neoplasms
- Being tested
- Bevacizumab, Oxaliplatin, Capecitabine, Irinotecan
- Keywords
- NSABP, bevacizumab, capecitabine, oxaliplatin, irinotecan, rectal cancer, colon cancer, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
7.5 mg/kg IV Day 1 every 21 days for eight cycles*
*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
OxaliplatinDrug
Also called Eloxatin
130 mg/m2 IV Day 1 every 21 days for eight cycles
CapecitabineDrug
Also called Xeloda
850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*#
*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression.
#For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
IrinotecanDrug
Also called Camptosar
200 mg/m2 IV Day 1 every 21 days for eight cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine |
| 2 | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Capecitabine; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year Progression-free Survival (PFS)
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Measured: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Secondary outcomes (4)
Objective Response Rate
Measured: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Toxicity - Adverse Events
Measured: Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
Overall Survival
Measured: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Duration of Response
Measured: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2008
- Study completionJun 2010
Why it stopped: The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
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 NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- Genentech, Inc., Hoffmann-La Roche, International Drug Development Institute
- Responsible party
- Sponsor
- Investigators
- Norman Wolmark, MD, Principal investigator, NSABP Foundation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314353
- Sponsor's protocol ID
- NSABP FC-BV-003
- Status last verified
- Oct 2021
- First submitted
- 11 Apr 2006
- Last updated
- 6 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00314353
- Acronym / sponsor ID
- NSABP FC-BV-003
- Conditions
- Colorectal Neoplasms
- Keywords
- NSABP, bevacizumab, capecitabine, oxaliplatin, irinotecan, rectal cancer, colon cancer, colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- Genentech, Inc., Hoffmann-La Roche, International Drug Development Institute
- Study start
- Mar 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Apr 2006 (estimated)
- Results
- Posted 2 Dec 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.
Detailed description
Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.
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: Bevacizumab, Drug: Oxaliplatin, Drug: Capecitabine |
| 2 | Experimental | Drug: Bevacizumab, Drug: Capecitabine, Drug: Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
- Evidence of adequate organ function (such as liver, kidneys, etc.)
Key exclusion criteria (5 listed)
- Diagnosis of anal cancer
- Patients who are candidates for surgery
- Patients who have received previous treatments
- Pregnant or lactating women
- History of chronic disease(s) or other serious medical conditions
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 |
|---|---|---|
| BevacizumabAlso: Avastin7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression. | Drug | 1, 2 |
| OxaliplatinAlso: Eloxatin130 mg/m2 IV Day 1 every 21 days for eight cycles | Drug | 1 |
| CapecitabineAlso: Xeloda850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID | Drug | 1, 2 |
| IrinotecanAlso: Camptosar200 mg/m2 IV Day 1 every 21 days for eight cycles | Drug | 2 |
Primary outcome
One-year Progression-free Survival (PFS)
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
4 secondary outcomes
Objective Response Rate
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Toxicity - Adverse Events
Time frame: Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
Overall Survival
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Duration of Response
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- 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.
Norman Wolmark, MD principal investigator
NSABP Foundation Inc
1 site 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, Oxaliplatin and Capecitabine in people with Colorectal Neoplasms, run by NSABP Foundation Inc at 1 site in United States.
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: stopped early, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 Dec 2008). 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?
One-year Progression-free Survival (PFS) (time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.). 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 6 Oct 2021.