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Colorectal NeoplasmsPhase 2QUATTRONCT02246049

A Multicenter, Clinical Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With mCRC

A Phase 2 study testing Bevacizumab, 5-fluorouracil and Irinotecan hydrochloride in people with Colorectal Neoplasms, run by EPS Corporation at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study to assess efficacy and tolerability of combination therapy FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Bevacizumab, 5-fluorouracil and Irinotecan hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteJapan
Study dates
May 2014to Feb 2017
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Written Informed consent.
  • Histopathologically proven diagnosis of colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
  • Not resectable metastatic colorectal cancer
  • Age at enrollment is >= 20 and <= 75 years
  • ECOG PS < 2 if age < 70 years, ECOG PS = 0 if age = 71-75 years
  • One or more measurable lesion in RECIST ver.1.1 criteria according to contrast enhanced CT chest / abdomen / pelvis diagnosis.
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  • Not previously treated with chemotherapy. ( Previous adjuvant by fluoropyrimidine monotherapy is allowed if more than 24 weeks have elapsed between the end of adjuvant therapy and first relapse.)
  • Vital organ functions (listed below) are preserved within 2 weeks prior to entry. Data recorded nearest to the entry should be referred. Blood transfusion or erythropoiesis stimulating agents less than 2 weeks prior to the tests are not allowed.
  • Neu. >= 1,500/cubicmillimeter Pt. >= 100,000/cubicmillimeter Hb. >= 9.0 g/dL T-bil. <= upper limit of normal (ULN)1.5 AST and ALT,ALP <= upper limit of normal (ULN)2.5 (<= ULN5 in case of liver metastasis) Serum creatinine <= upper limit of normal (ULN) 1.5 PT-INR < 1.5 Proteinuria <= 2+
  • UGT1A1 genotype tested. Categorized into Wild or single Hetero.

Who cannot join

  • Previously treated with irradiation to bone marrow constituting 20% or more of irradiation field.
  • Untreated brain metastases or spinal cord compression or primary brain tumors.
  • History of CNS disease.[except for asymptomatic Lacunar stroke]
  • Requiring chronic systemic corticosteroid treatment.
  • Current or recent ongoing treatment with anticoagulants.
  • Clinically significant cardiovascular disease for example cerebrovascular accidents, myocardial infarction, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication.
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  • Treatment with any investigational drug within 4 weeks.
  • Patient with Uncontrolled hypertension, Uncontrolled diabetes, Uncontrolled diarrhea, >=grade 1 peripheral neuropathy, Active peptic ulcer, Non-healing wound, Clinically important diseases.
  • Major surgical procedure within 28 days prior to study treatment start, open biopsy, or significant traumatic injury, or anticipation of the need for major surgical procedure.[except for implantation of central venous catheter and port system.]
  • Lack of physical integrity of the upper gastrointestinal tract.
  • Pregnant women, lactating woman , positive by pregnancy test , wishing to become pregnant, and Sexually active males.
  • Hepatitis B or hepatitis C. Evidence of HIV infection.
  • Previous Chemotherapy for other organs.
  • Other active co-existing malignancies.
  • History / Presence of thrombosis within 1 year requiring medication.
  • History / Presence of paralytic ileus, obstruction or gastrointestinal perforation.
  • Malignant coelomic fluid required drainage.
  • History of allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications.
  • History of fluoropyrimidine severe side effects caused by DPD defect.
  • Interstitial pneumonitis or pulmonary fibrosis.
  • Evidence or requiring systemic treatment for Infectious disease.
  • Patient who is judged by the investigator to be inappropriate for study participation for any reason.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • EPS Corporation

    Shinjuku, Tokyo, 162-0814

Other trials in Japan

About this study

Official title: A Multicenter, Clinical Phase II Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With Metastatic Colorectal Cancer

The purpose of this study to assess efficacy and tolerability of combination therapy FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic colorectal cancer.

Read the detailed description

This is a single-arm, multicentre phase II study evaluating the efficacy and safety of Bevacizumab (BV) in combination with oxaliplatin, irinotecan hydrochloride, fluorouracil, and leucovorin calcium regimen ( FOLFOXIRI +BV ; Falcone et al. ASCO2013) as first-line treatment for Japanese metastatic colorectal cancer patients.

This study is composed two steps because of collecting safety issue in Japanese patient.

As First step (Step 1), It assess on the initial safety information in ten Japanese patients of the end of 2nd cycle. it is evaluated by DMC.

In parallel with the confirmation of the initial safety issue, register up to 65 cases in total and Step 1 patient, to evaluate the efficacy and safety (Step2).

Keywords
Metastatic colorectal cancer, bevacizumab, FOLFOXIRI
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02246049
Study groupRoleWhat they receive
FOLFOXIRI plus bevacizumabExperimentalInduction therapy is followed by the maintenance therapy. [Induction treatment:FOLFOXIRI plus bevacizumab] Administered for a maximum of 12 cycles. BV: 5mg/kg (d.i.v.) L-OHP: 85 mg/sq.m (d.i.v.) CPT-11:165mg/sq.m (d.i.v.) l-LV:200mg/sq.m (d.i.v.) 5-FU:3,200mg/sq.m (c.i.v.) Administered every 2 weeks. [Maintenance treatment:5-FU / I-LV plus bevacizumab] BV:5mg/kg (d.i.v.) l-LV:200mg/sq.m (d.i.v.) 5-FU:3,200mg/sq.m (c.i.v.) Administered every 2 weeks.
Receives: Biological: Bevacizumab; Drug: 5-fluorouracil; Drug: Irinotecan hydrochloride; Drug: Leucovorin calcium; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) at 10 months

    PFS by investigator-reported measurements according to CT image. PFS was calculated from the day of treatment start to the first observation of progression disease (PD) or death from any cause.

    PD was defined as Overall Response by RECIST criteria v1.1 according to CT image.

    Measured: PFS rate at 10 months from study entry

Secondary outcomes (10)

  1. Response rate (RR) by central review.

    Response evaluation was performed according to RECIST criteria v1.1.

    Measured: Up to 18 months

  2. Response rate (RR) by investigator-reported measurements.

    Response evaluation was performed according to RECIST criteria v1.1.

    Measured: Up to 30 months

  3. PFS by central review according to CT image.

    PFS was calculated from the day of treatment start to the first observation of progression disease (PD) or death from any cause.

    Measured: Up to 18 months

  4. Overall survival (OS)

    OS was calculated from the day of registration in this study to death from any cause.

    Measured: Up to 30 months

  5. Efficacy by RAS status ; RR,PFS,OS

    RR,PFS,OS according to tumor RAS status.

    Measured: Up to 30 months

  6. Incidence of adverse events

    Adverse events were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All adverse events was collected in duration from starting treatment to whichever shorter "after 30 days from withdrawal treatment" or "later treatment was started".

    Measured: Up to 30 months

  7. Time to treatment-failure

    Measured: Up to 30 months

  8. Completion rate in Induction treatment

    Measured: Up to 30 months

  9. Relative Dose Intensity

    Measured: Up to 30 months

  10. Treatment duration

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02246049
Sponsor's protocol ID
QUATTRO
Acronym
QUATTRO
Status last verified
Jun 2017
First submitted
12 Sep 2014
Last updated
19 Jun 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, 5-fluorouracil and Irinotecan hydrochloride in people with Colorectal Neoplasms, run by EPS Corporation at 1 site in Japan.

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 10 inclusion and 22 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 19 Jun 2017. 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 Japan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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) at 10 months (time frame: PFS rate at 10 months from study entry). 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 NCT02246049.

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 19 Jun 2017.

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