Metastatic Colorectal CancerPhase 2BEVATOMOXNCT01532804
2nd-line Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing bevacizumab, oxaliplatin and 5FU combination and Bevacizumab, oxaliplatin and raltitrexed combination in people with Metastatic Colorectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- bevacizumab, oxaliplatin and 5FU combination and Bevacizumab, oxaliplatin and raltitrexed combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2011to Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven colorectal cancer
- Resected or asymptomatic primary tumor
- Metastatic colorectal cancer not eligible for curative surgery
- No major surgery within four weeks of the start of study treatment
- At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1)
- Disease progression after failure of irinotecan-based chemotherapy
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- Bone metastases are allowed if there is at least one other measurable metastatic site
- CT scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment
- WHO PS ≤ 2
- Platelet count >= 100,000 mm3
- Hemoglobin > 10g/dl
- Bilirubin < 1.5 ULN, AST/ALT < 5 ULN
- Serum creatinine < 1.5 ULN, creatinine clearance > 60 ml/min (Cockcroft)
- A time period of 4 weeks should be respected between the end of previous treatments and study enrollment
- Negative pregnancy test in women of childbearing potential
- Male or female using an effective contraceptive method
- Absence of known or symptomatic brain metastases
- Life expectancy > 3 months
- Informed consent signed prior any study specific procedures
Who cannot join
- Prior raltitrexed-based chemotherapy
- Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months)
- Uncontrolled arterial hypertension defined as systolic pressure > 150 mm Hg or diastolic pressure > 100 mm Hg
- Malignant hypertension or hypertensive encephalopathy
- Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry
- Hemorrhagic diathesis or significant pathology of coagulation
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- Peripheral neuropathy grade>2 (NCI-CTC v4.0)
- Hemoptysis < 1 month
- Venous access device (PAC) or any other minor surgery such as a biopsy within the last 7 days
- Symptomatic brain metastases or carcinomatous meningitis
- History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer)
- Severe bacterial or fungal infection (Grade > 2 NCI-CTCAE v.4.0)
- Known or suspected sensitivity to one of the study drugs
- Pregnant or breastfeeding women
- Previous enrollment in an investigational drug study within the last 4 weeks
- Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer
This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.
Read the detailed description
Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:
- Center
- Number of metastatic sites: 1 versus > 1
- Bevacizumab-based first-line therapy: Yes versus No
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- bevacizumab, oxaliplatin and 5FU combination, Bevacizumab, oxaliplatin and raltitrexed combination
- Keywords
- Unresectable metastases
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab, oxaliplatin and 5FU combinationDrug
Bevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively.
Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles)
Bevacizumab, oxaliplatin and raltitrexed combinationDrug
Bevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively.
Oxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | FOLFOX6 + bevacizumab (D1=D15, 12 cycles) Receives: Drug: bevacizumab, oxaliplatin and 5FU combination |
| Arm B | Experimental | Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles) Receives: Drug: Bevacizumab, oxaliplatin and raltitrexed combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
DFS is estimated from the date of randomization until the first date of objectively documented event or death
Measured: 6 months
Secondary outcomes (5)
Treatment-related toxicity
Treatment-related toxicity is evaluated according to the NCI-CTCAE v.4 criteria.
Measured: 6 months
Objective response rate
Objective response rate is evaluated according to the RECIST V 1.1 criteria.
Measured: Every 9 weeks
Overall survival
OS is estimated from the date of randomization until the date of death from any cause
Measured: unk
Cost-effectiveness study
The cost-effectiveness study includes the number of hospital stays (treatment and toxicity), the global cost of treatments, and the cost of hospital stays due to treatment-induced toxicity
Measured: 6 months
Quality of life by using the quality of life questionnaire score
Quality of life is measured using the QLQ-C30 questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study start28 Jul 2011
- Primary completion12 May 2016
- Study completionJan 2019
Why it stopped: too slow recruiting
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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Samalin-Scalzi, MD, Principal investigator, Val d'Aurelle Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532804
- Sponsor's protocol ID
- BEVATOMOX
- Other IDs
- 2010-023447-15
- Acronym
- BEVATOMOX
- Status last verified
- Dec 2019
- First submitted
- 10 Feb 2012
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Samalin E, Senellart H, Thezenas S, Jacquot S, Ellis S, Akouz FK, Fiess C, Ramdani M, Portales F, Assenat E, Ychou M, Mineur L, Mazard T. The BEVATOMOX phase II trial: raltitrexed/oxaliplatin/bevacizumab vs mFOLFOX6/bevacizumab in 2nd-line metastatic colorectal cancer. Oncologist. 2026 Feb 5;31(3):oyag006. doi: 10.1093/oncolo/oyag006.
PubMed 41537257
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01532804
- Acronym / sponsor ID
- BEVATOMOX / BEVATOMOX
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Unresectable metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too slow recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 28 Jul 2011 (actual)
- Primary completion
- 12 May 2016 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 15 Feb 2012 (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 phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.
Detailed description
Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:
- Center
- Number of metastatic sites: 1 versus > 1
- Bevacizumab-based first-line therapy: Yes versus No
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: bevacizumab, oxaliplatin and 5FU combinationFOLFOX6 + bevacizumab (D1=D15, 12 cycles) |
| Arm B | Experimental | Drug: Bevacizumab, oxaliplatin and raltitrexed combinationRaltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically proven colorectal cancer
- Resected or asymptomatic primary tumor
- Metastatic colorectal cancer not eligible for curative surgery
- No major surgery within four weeks of the start of study treatment
- At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1)
Key exclusion criteria (16 listed)
- Prior raltitrexed-based chemotherapy
- Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months)
- Uncontrolled arterial hypertension defined as systolic pressure > 150 mm Hg or diastolic pressure > 100 mm Hg
- Malignant hypertension or hypertensive encephalopathy
- Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry
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, oxaliplatin and 5FU combinationBevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively. Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles) | Drug | Arm A |
| Bevacizumab, oxaliplatin and raltitrexed combinationBevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively. Oxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min | Drug | Arm B |
Primary outcome
Disease-free survival
Time frame: 6 months
DFS is estimated from the date of randomization until the first date of objectively documented event or death
5 secondary outcomes
Treatment-related toxicity
Time frame: 6 months
Objective response rate
Time frame: Every 9 weeks
Overall survival
Time frame: unk
Cost-effectiveness study
Time frame: 6 months
Quality of life by using the quality of life questionnaire score
Time frame: 6 months
Results and safety
The study was stopped early (reason given: too slow recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 41537257Samalin E, Senellart H, Thezenas S, Jacquot S, Ellis S, Akouz FK, Fiess C, Ramdani M, Portales F, Assenat E, Ychou M, Mineur L, Mazard T. The BEVATOMOX phase II trial: raltitrexed/oxaliplatin/bevacizumab vs mFOLFOX6/bevacizumab in 2nd-line metastatic colorectal cancer. Oncologist. 2026 Feb 5;31(3):oyag006. doi: 10.1093/oncolo/oyag006.
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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.
Emmanuelle Samalin-Scalzi, MD principal investigator
Val d'Aurelle Cancer Institute
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 5FU combination and Bevacizumab, oxaliplatin and raltitrexed combination in people with Metastatic Colorectal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 19 inclusion and 16 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 26 Dec 2019. 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?
The study was stopped early (reason given: too slow recruiting). Results are not available in the source record.
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?
Disease-free survival (time frame: 6 months). 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 NCT01532804, 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 26 Dec 2019.