Colorectal CancerPhase 2NCT00544011
Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
A Phase 2 study testing bevacizumab, capecitabine and fluorouracil in people with Colorectal Cancer, run by Hopital Jean Minjoz at 1 site in France.
Trial summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- bevacizumab, capecitabine and fluorouracil
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to not given
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WHO performance status 0-1
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Transaminases ≤ 2 times ULN (5 times ULN if liver metastases present)
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- Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases present)
- Creatinine ≤ 130 μmol/L OR creatinine clearance ≥ 30 mL/min
- Proteinuria < 2+ or urine protein ≤ 1 g/24 hours
- Not pregnant or nursing
- Fertile patients of must use effective contraception
- See Disease Characteristics
Who cannot join
- Uncontrolled cardiac disease
- Prior cerebral vascular accident
- Uncontrolled arterial hypertension
- Severe renal or hepatic insufficiency
- Prior arteriopathy
- Bleeding disorder or nonhealing wound
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- Coagulopathy
- Other malignancy within the past 2 years except basal cell or squamous cell skin cancer or curatively treated carcinoma of the cervix
- Psychiatric disorder compromising comprehension or participation in the study
- Intestinal occlusion or subocclusion not caused by medical therapy
- PRIOR CONCURRENT THERAPY:
- Prior adjuvant bevacizumab or irinotecan hydrochloride
- Concurrent aspirin (> 325 mg/day) or therapeutic anticoagulants
- Surgery in the past 28 days
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, 25030
Christophe Borg, PhD, 33-381-668-705, christophe.borg@efs.sante.fr
About this study
Official title: Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the objective response (complete and partial) rate in patients with metastatic colorectal adenocarcinoma treated with bevacizumab and modified FOLFIRI 3 chemotherapy.
Secondary
- Determine progression-free and overall survival.
- Determine the tolerance to this regimen.
- Evaluate the resectability rate.
- Evaluate biological markers predictive of the efficacy of this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1, irinotecan hydrochloride IV over 90 minutes on days 1 and 3, and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
At 14 days after completing chemotherapy, patients with progressive or stable disease receive maintenance therapy comprising bevacizumab and capecitabine.
Biological specimens are collected at baseline and before the fourth course of chemotherapy.
After completion of study therapy, patients are followed every 3 months for 2 years.
- Conditions
- Colorectal Cancer
- Being tested
- bevacizumab, capecitabine, fluorouracil, irinotecan hydrochloride, diagnostic laboratory biomarker analysis
- Keywords
- stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
capecitabineDrug
fluorouracilDrug
diagnostic laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response (complete and partial) rate
Secondary outcomes (5)
Progression-free survival
Overall survival
Tolerance
Resectability rate
Biomarkers predictive of efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startApr 2007
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.
- 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
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Jean Minjoz
- Sponsor type
- University, hospital or other
- Investigators
- Christophe Borg, PhD, Hopital Jean Minjoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544011
- Sponsor's protocol ID
- CDR0000564118
- Other IDs
- CHRB-Folfiri-III-Avastin, INCA-RECF0432
- Status last verified
- Jul 2009
- First submitted
- 13 Oct 2007
- Last updated
- 27 Jun 2011
- Results posted
- No
Publications
Jary M, Lecomte T, Bouche O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Leger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.
PubMed 27472156
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00544011
- Acronym / sponsor ID
- CDR0000564118
- Conditions
- Colorectal Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Hopital Jean MinjozUniversity, hospital or other
- Study start
- Apr 2007
- First posted
- 16 Oct 2007 (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.
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the objective response (complete and partial) rate in patients with metastatic colorectal adenocarcinoma treated with bevacizumab and modified FOLFIRI 3 chemotherapy.
Secondary
- Determine progression-free and overall survival.
- Determine the tolerance to this regimen.
- Evaluate the resectability rate.
- Evaluate biological markers predictive of the efficacy of this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1, irinotecan hydrochloride IV over 90 minutes on days 1 and 3, and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
At 14 days after completing chemotherapy, patients with progressive or stable disease receive maintenance therapy comprising bevacizumab and capecitabine.
Biological specimens are collected at baseline and before the fourth course of chemotherapy.
After completion of study therapy, patients are followed every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- WHO performance status 0-1
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Key exclusion criteria (14 listed)
- Uncontrolled cardiac disease
- Prior cerebral vascular accident
- Uncontrolled arterial hypertension
- Severe renal or hepatic insufficiency
- Prior arteriopathy
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 |
|---|---|---|
| bevacizumab | Biological | – |
| capecitabine | Drug | – |
| fluorouracil | Drug | – |
| irinotecan hydrochloride | Drug | – |
| diagnostic laboratory biomarker analysis | Other | – |
Primary outcome
Objective response (complete and partial) rate
5 secondary outcomes
Progression-free survival
Overall survival
Tolerance
Resectability rate
Biomarkers predictive of efficacy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Derived from this study: PubMed 27472156Jary M, Lecomte T, Bouche O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Leger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.
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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.
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, France
Christophe Borg, PhD
Hopital Jean Minjoz
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, capecitabine and fluorouracil in people with Colorectal Cancer, run by Hopital Jean Minjoz at 1 site in France.
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 12 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response (complete and partial) rate. 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 NCT00544011, 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 27 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.