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AzTrials

Metastatic Colorectal CancerPhase 2BeTRINCT02497157

Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer

A Phase 2 study testing Oxaliplatin (L-OHP), Irinotecan hydrochloride hydrate (CPT-11) and Continuous intravenous infusion of fluorouracil (CIV 5-FU) in people with Metastatic Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 7 sites 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 is to evaluate the efficacy and safety of fluorouracil (5-FU), levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who harbor Uridine diphosphate (UDP)-glucuronosyl… Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Oxaliplatin (L-OHP), Irinotecan hydrochloride hydrate (CPT-11) and Continuous intravenous infusion of fluorouracil (CIV 5-FU)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
7 sitesJapan
Study dates
21 May 2015to Jun 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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the colon or rectum.
  • Unresectable or recurrent colorectal cancer patient.
  • One or more measurable lesion in RECIST ver.1.1 criteria.
  • No prior chemotherapy, immunotherapy, and radiotherapy.
  • Life expectancy at least 3 months.
  • Patients who harbor UGT1A1*1/*1, *1/*6 or *1/*28.
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  • The Eastern Cooperative Oncology Group (ECOG) performance status of =<1.
  • Vital organ functions (listed below) are preserved within 14 days prior to entry.
  • White blood cell count (WBC): >= 3,000 per cubic millimeter Neu: >= 1,500 per cubic millimeter Platelet count (PLT): >= 100,000 per cubic millimeter Aspartate aminotransferase (AST/GOT) and alanine aminotransferase (ALT/GPT): <= 100 IU/L, <= 150 IU/L in cases with liver metastasis T-bil: <= 1.5 mg/dL Serum creatinine: <= 1.50 mg/dL Proteinuria: <= 1+ Prothrombin time-international normalized ratio (PT-INR): < 1.5
  • Written informed consent.

Who cannot join

  • Vermiform appendix cancer and anal canal cancer.
  • Administration of blood products/ granulocyte-colony stimulating factor (G-CSF), and blood transfusion within 14 days prior to enrollment.
  • Synchronous multiple malignancy or metachronous multiple malignancy less than 5 years disease free interval.
  • Hepatitis B virus antigen (HBs-Ag)(+), or hepatitis C virus antibody (HCV-Ab)(+).
  • History of severe allergy.
  • Sensory alteration or paresthesia interfering with function.
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  • Prior radiotherapy for ilium and abdomen.
  • Infectious disease.
  • Uncontrolled diarrhea.
  • Ileus or bowel obstruction.
  • Interstitial lung disease or pulmonary fibrosis.
  • Malignant coelomic fluid required drainage.
  • Administration of atazanavir sulfate.
  • Heart disease to be clinically problem.
  • Major surgical procedure or intestinal resection within 28 days prior to enrollment or colostomy within 14 days prior to enrollment.
  • Known brain metastasis or strongly suspected of brain metastasis.
  • History of a thromboembolic disease.
  • Receiving anti-platelet drugs.
  • Poorly controlled gastrointestinal ulcer.
  • History of intestinal perforation within the past 12 months.
  • Poorly controlled hypertension.
  • Poorly controlled diabetes mellitus.
  • Severe mental disorders.
  • Women who are pregnant or nursing, men and women who wish to conceive a child or with no intention to contraception.
  • Any other cases who are regarded as inadequate for study enrollment by investigators.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Japan7 sites

  • Kagawa University Hospital

    Kita-gun, Miki-cho, Kagawa-ken, 761-0793

  • Tokushima Red Cross Hospital

    Komatsushimachō, Tokushima, 773-8502

  • Kawasaki Medical School Hospital

    Kurashiki, Okayama-ken, 701-0192

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime, 790-8524

  • Okayama Saiseikai General Hospital

    Okayama, Okayama-ken, 700-8511

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Okayama Rosai Hospital

    Okayama, Okayama-ken, 702-8055

Other trials in Japan

About this study

Official title: Phase II Trial of FOLFOXIRI + Bevacizumab in Patients With Untreated Metastatic Colorectal Cancer

The purpose of this study is to evaluate the efficacy and safety of fluorouracil (5-FU), levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who harbor Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) *1/*1, *1/*6 or *1/*28.

Being tested
Oxaliplatin (L-OHP), Irinotecan hydrochloride hydrate (CPT-11), Continuous intravenous infusion of fluorouracil (CIV 5-FU), Levofolinate calcium (l-LV), Bevacizumab (Bmab)
Keywords
bevacizumab, oxaliplatin, irinotecan, hydrochloride hydrate, fluorouracil, levofolinate calcium
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Oxaliplatin (L-OHP)Drug

  • Irinotecan hydrochloride hydrate (CPT-11)Drug

  • Continuous intravenous infusion of fluorouracil (CIV 5-FU)Drug

  • Levofolinate calcium (l-LV)Drug

  • Bevacizumab (Bmab)Drug

Study groups in NCT02497157
Study groupRoleWhat they receive
Treatment ArmExperimentalPatients receive FOLFOXIRI plus bevacizumab [oxaliplatin (L-OHP): 85 mg/sq.m., irinotecan hydrochloride hydrate (CPT-11): 165 mg/sq.m., continuous intravenous infusion of fluorouracil (CIV 5-FU): 3,200 mg/sq.m., Levofolinate calcium (l-LV): 200 mg/sq.m., bevacizumab: 5 mg/kg]. The treatment will be repeated every 2 weeks, for up to 12 cycles, unless the disease progression, unacceptable toxicity, tumor resection or consent withdrawal.
Receives: Drug: Oxaliplatin (L-OHP); Drug: Irinotecan hydrochloride hydrate (CPT-11); Drug: Continuous intravenous infusion of fluorouracil (CIV 5-FU); Drug: Levofolinate calcium (l-LV); Drug: Bevacizumab (Bmab)

What is being measured

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

  1. Response rate (RR) by response evaluation criteria in solid tumors (RECIST v1.1)

    RR will be calculated as the ratio of the number of eligible patients who experienced a confirmed Complete response(CR) or Partial response(PR) by RECIST v1.1.

    Measured: Up to 18 months

Secondary outcomes (6)

  1. Time to treatment failure (TTF)

    TTF is defined as the time from date of starting treatment until date of treatment discontinuation, the first documented progression or death from any cause, whichever comes first.

    Measured: Up to 18 months

  2. Progression-free survival (PFS)

    PFS is defined as the time from date of starting treatment until date of the first documented progression or death from any cause, whichever comes first.

    Measured: Up to 3 years

  3. Overall survival (OS)

    OS is defined as the time from date of starting treatment until date of death from any cause.

    Measured: Up to 3 years

  4. R0 resection rate

    R0 resection rate will be calculated as the ratio of the number of eligible patients who experienced a complete (R0) resection.

    Measured: Up to 18 months

  5. Relative dose intensity (RDI)

    RDI will be calculated as the ratio of actual delivered dose intensity in comparison with planned dose intensity. Dose intensity (DI) is defined as the amount of drug delivered per unit time, expressed in mg/m2/week.

    Measured: Up to 18 months

  6. Incidence of adverse events

    Measured: Up to 3 years

Timeline

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

  1. First posted14 Jul 2015 (estimated)
  2. Study start21 May 2015
  3. Primary completionJun 2019
  4. Study completionJun 2019

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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02497157
Sponsor's protocol ID
TRICC1414
Other IDs
UMIN000017102
Acronym
BeTRI
Status last verified
Jun 2020
First submitted
25 Jun 2015
Last updated
17 Jun 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin (L-OHP), Irinotecan hydrochloride hydrate (CPT-11) and Continuous intravenous infusion of fluorouracil (CIV 5-FU) in people with Metastatic Colorectal Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 7 sites 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 25 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 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

Response rate (RR) by response evaluation criteria in solid tumors (RECIST v1.1) (time frame: Up to 18 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 NCT02497157.

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 17 Jun 2020.

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