Colorectal CancerPhase 2DEEPERNCT02515734
A Study of FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab
A Phase 2 study testing fluorouracil, Leucovorin and irinotecan in people with Colorectal Cancer, run by Japan Clinical Cancer Research Organization.
Trial summary
This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- fluorouracil, Leucovorin and irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jun 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed colorectal cancer
- RAS wild-type
- Measurable lesion by RECIST (Ver.1.1)
- No past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.In the case of recurrence, no treatment for the first recurrence lesion after operation
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.The case >=71 years is PS0.
- Life expectancy of more than 6 months
Show all 19Show fewer
- Patients have enough organ function for study treatment within 14 days before enrollment;
- White blood cell (WBC)>=3,000/mm3, <12,000/mm3.
- Neu>=1,500/mm3.
- Platelet count (PLT) >=10.0x104/mm3.
- Hb>=9.0g/dL.
- Total Bilirubin<=1.5x Upper Limited Normal (ULN)
- aspartate aminotransferase (AST) <=2.5xULN.
- alanine aminotransferase (ALT) <=2.5xULN.
- Creatinine<=1.5xULN.
- Proteinuria<=1+.
- prothrombin time-international normalized ratio (PT-INR) <=1.5
- Must be able to swallow tablets
- Written informed consent
Who cannot join
- Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
- Lynch syndrome
- Brain metastases
- Infectious disease
- Interstitial lung disease or pulmonary fibrosis
- Comorbidity or history of serious heart failure
Show all 35Show fewer
- History of thromboembolic events
- Cerebrovascular disease
- History of hemoptysis/hematemesis
- Uncontrolled hypertension (systolic BP>180mmHg, or diastolic BP>100mmHg)
- Sensory alteration or paresthesia interfering with function
- Large quantity of pleural, abdominal or cardiac effusion
- Severe comorbidity (renal failure, liver failure, hypertension, etc)
- Prior radiotherapy for primary and metastases leision
- Men/women who are unwilling to avoid pregnancy
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test
- History of severe allergy
- HBsAg positive or active viral hepatitis
- Administration of blood products/ Granulocyte-Colony Stimulating Factor (G-CSF), and blood transfusion within 14 days
- Surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgery within 28 days
- Systematic administration of antiplatelet drug or non steroid anti-inflammatory drugs (NSAIDs)
- Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy
- History of gastrointestinal perforation within 1 year
- Unhealed traumatic bone fracture
- Uncontrolled diarrhea
- History of organ recipient
- Prior cetuximab/bevacizumab/Irinotecan/Oxaliplatin treatment (Adjuvant therapy by Oxaliplatin is excluded)
- Administration of atazanavir sulfate
- Jaundice
- Ileus or bowel obstruction
- Clinical diagnosis of Alzheimer's Disease
- Insulin dependent diabetes
- Thyroid disease
- Any other cases who are regarded as inadequate for study enrollment by investigators
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Phase II Study to Investigate the Deepness of Response of FOLFOXIRI Plus Cetuximab (Erbitux) Versus FOLFOXIRI Plus Bevacizumab as the First-line Therapy in Metastatic Colorectal Cancer Patients With RAS Wild-type Tumors: DEEPER
This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors.
Read the detailed description
This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors. In this study the investigators employed deepness of response as a primary endpoint.
- Conditions
- Colorectal Cancer
- Being tested
- fluorouracil, Leucovorin, irinotecan, oxaliplatin, bevacizumab
- Keywords
- FOLFOXIRI, Bmab, Cmab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
Also called 5-fluorouracil, 5-FU
LeucovorinDrug
Also called Levofolinate
irinotecanDrug
Also called CPT-11
oxaliplatinDrug
Also called eloxatin
bevacizumabBiological
cetuximabBiological
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI+Bmab | Active comparator | Patients in the FOLFOXIRI + Bmab group receive until 12 cycles of FOLFOXIRI plus bevacizumab, consisting of a 30-minute infusion of bevacizumab at a dose of 5 mg per kilogram, a 60-minute infusion of irinotecan at a dose of 150 mg per square meter, and a 120-minute infusion of oxaliplatin at a dose of 85 mg per square meter and a concomitant 120-minute infusion of leucovorin at a dose of 200 mg per square meter, followed by a 48-hour continuous infusion of fluorouracil to a total dose of 2400 mg per square meter. Cycles were repeated every 14 days. After 13 cycles, patients receive fluorouracil, leucovorin and bevacizumab every 14 days until disease progression. Receives: Drug: fluorouracil; Drug: Leucovorin; Drug: irinotecan; Drug: oxaliplatin; Biological: bevacizumab |
| FOLFOXIRI+Cmab | Experimental | Patients in the experimental group received until 12 cycles of FOLFOXIRI plus cetuximab, consisting of a 30-minute infusion of cetuximab first time at a dose of 400 mg per kilogram, after the second time at a dose of 250mg per kilogram, a 60-minute infusion of irinotecan at a dose of 150 mg per square meter, and a 120-minute infusion of oxaliplatin at a dose of 85 mg per square meter and a concomitant 120-minute infusion of leucovorin at a dose of 200 mg per square meter, followed by a 48-hour continuous infusion of fluorouracil to a total dose of 2400 mg per square meter. Cycles were repeated every 14 days. After 13 cycles, patients receive fluorouracil, leucovorin and cetuximab every 14 days until disease progression. Receives: Drug: fluorouracil; Drug: Leucovorin; Drug: irinotecan; Drug: oxaliplatin; Biological: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best deepness of response
The maximum tumor shrinkage rates by Response Evaluation Criteria in Solid Tumors (RECIST) throughout the treatments
Measured: up to 2 years
Secondary outcomes (7)
Early tumor shrinkage
The rates of tumor shrinkage by RECIST at 8 weeks
Measured: at 8 weeks
Response rate
Measured: up to 2 years
Deepness of response
The tumor shrinkage rates by RECIST at 4 months
Measured: at 4 months
Overall survival
Measured: up to 2 years
Progression free survival
Measured: up to 2 years
Rate of curatively resected metastatic lesion
Measured: up to 2 years
Number of adverse events
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japan Clinical Cancer Research Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toshifusa Nakajima, MD, Study director, Japan Clinical Cancer Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515734
- Sponsor's protocol ID
- JACCRO CC-13
- Acronym
- DEEPER
- Status last verified
- Aug 2015
- First submitted
- 12 Jul 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study to Investigate the Deepness of Response of FOLFOXIRI Plus Cetuximab (Erbitux) Versus FOLFOXIRI Plus Bevacizumab as the First-line Therapy in Metastatic Colorectal Cancer Patients With RAS Wild-type Tumors: DEEPER
- ClinicalTrials.gov ID
- NCT02515734
- Acronym / sponsor ID
- DEEPER / JACCRO CC-13
- Conditions
- Colorectal Cancer
- Keywords
- FOLFOXIRI, Bmab, Cmab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Japan Clinical Cancer Research OrganizationUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 5 Aug 2015 (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 study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors.
Detailed description
This study is to verify the advantage of FOLFOXIRI plus cetuximab over FOLFOXIRI plus bevacizumab as the first-line therapy in metastatic colorectal cancer patients with RAS wild-type tumors. In this study the investigators employed deepness of response as a primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI+Bmab | Active comparator | Drug: fluorouracil, Drug: Leucovorin, Drug: irinotecan, Drug: oxaliplatin, Biological: bevacizumabPatients in the FOLFOXIRI + Bmab group receive until 12 cycles of FOLFOXIRI plus bevacizumab, consisting of a 30-minute infusion of bevacizumab at a dose of 5 mg per kilogram, a 60-minute infusion of irinotecan at a dose of 150 mg per square meter, and a 120-minute infusion of oxaliplatin at a dose of 85 mg per square meter and a concomitant 120-minute infusion of leucovorin at a dose of 200 mg per square meter, followed by a 48-hour continuous infusion of fluorouracil to a total dose of 2400 mg per square meter. Cycles were repeated every 14 days. After 13 cycles, patients receive fluorouracil, leucovorin and bevacizumab every 14 days until disease progression. |
| FOLFOXIRI+Cmab | Experimental | Drug: fluorouracil, Drug: Leucovorin, Drug: irinotecan, Drug: oxaliplatin, Biological: cetuximabPatients in the experimental group received until 12 cycles of FOLFOXIRI plus cetuximab, consisting of a 30-minute infusion of cetuximab first time at a dose of 400 mg per kilogram, after the second time at a dose of 250mg per kilogram, a 60-minute infusion of irinotecan at a dose of 150 mg per square meter, and a 120-minute infusion of oxaliplatin at a dose of 85 mg per square meter and a concomitant 120-minute infusion of leucovorin at a dose of 200 mg per square meter, followed by a 48-hour continuous infusion of fluorouracil to a total dose of 2400 mg per square meter. Cycles were repeated every 14 days. After 13 cycles, patients receive fluorouracil, leucovorin and cetuximab every 14 days until disease progression. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed colorectal cancer
- RAS wild-type
- Measurable lesion by RECIST (Ver.1.1)
- No past history of chemotherapy in the case of unresectable primary lesion/distant metastasis/lymph node metastasis.In the case of recurrence, no treatment for the first recurrence lesion after operation
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.The case >=71 years is PS0.
Key exclusion criteria (35 listed)
- Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
- Lynch syndrome
- Brain metastases
- Infectious disease
- Interstitial lung disease or pulmonary fibrosis
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 |
|---|---|---|
| fluorouracilAlso: 5-fluorouracil, 5-FU | Drug | FOLFOXIRI+Bmab, FOLFOXIRI+Cmab |
| LeucovorinAlso: Levofolinate | Drug | FOLFOXIRI+Bmab, FOLFOXIRI+Cmab |
| irinotecanAlso: CPT-11 | Drug | FOLFOXIRI+Bmab, FOLFOXIRI+Cmab |
| oxaliplatinAlso: eloxatin | Drug | FOLFOXIRI+Bmab, FOLFOXIRI+Cmab |
| bevacizumab | Biological | FOLFOXIRI+Bmab |
| cetuximab | Biological | FOLFOXIRI+Cmab |
Primary outcome
Best deepness of response
Time frame: up to 2 years
The maximum tumor shrinkage rates by Response Evaluation Criteria in Solid Tumors (RECIST) throughout the treatments
7 secondary outcomes
Early tumor shrinkage
Time frame: at 8 weeks
Response rate
Time frame: up to 2 years
Deepness of response
Time frame: at 4 months
Overall survival
Time frame: up to 2 years
Progression free survival
Time frame: up to 2 years
Rate of curatively resected metastatic lesion
Time frame: up to 2 years
Number of adverse events
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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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.
Toshifusa Nakajima, MD study director
Japan Clinical Cancer Research Organization
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluorouracil, Leucovorin and irinotecan in people with Colorectal Cancer, run by Japan Clinical Cancer Research Organization.
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 35 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 5 Aug 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Masashi Fujii, MD (+81-3-5579-9882, masashi.fujii@gioncology.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best deepness of response (time frame: up to 2 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 5 Aug 2015.