Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer
BeTRI
Phase II Trial of FOLFOXIRI + Bevacizumab in Patients With Untreated Metastatic Colorectal Cancer
2 other identifiers
interventional
45
1 country
7
Brief 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 transferase 1A1 (UGT1A1) \*1/\*1, \*1/\*6 or \*1/\*28.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2015
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2015
CompletedFirst Submitted
Initial submission to the registry
June 25, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 17, 2020
June 1, 2020
4 years
June 25, 2015
June 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to 18 months
Secondary Outcomes (6)
Time to treatment failure (TTF)
Up to 18 months
Progression-free survival (PFS)
Up to 3 years
Overall survival (OS)
Up to 3 years
R0 resection rate
Up to 18 months
Relative dose intensity (RDI)
Up to 18 months
- +1 more secondary outcomes
Other Outcomes (2)
Early tumor shrinkage (ETS) rates in 8 weeks after starting the treatment, evaluated by RECIST v1.1
Baseline (week 0), week 8
Deepness of response (DoR)
Up to 3 years
Study Arms (1)
Treatment Arm
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Matsuyama Red Cross Hospital
Matsuyama, Ehime, 790-8524, Japan
Kagawa University Hospital
Kita-gun, Miki-cho, Kagawa-ken, 761-0793, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, 701-0192, Japan
Okayama Saiseikai General Hospital
Okayama, Okayama-ken, 700-8511, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Okayama Rosai Hospital
Okayama, Okayama-ken, 702-8055, Japan
Tokushima Red Cross Hospital
Komatsushimachō, Tokushima, 773-8502, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katsunori Shinozaki, MD, Ph.D.
Hiroshima Prefectural Hospital
- PRINCIPAL INVESTIGATOR
Tomohiro Nishina, MD, Ph.D.
National Hospital Organization Shikoku Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2015
First Posted
July 14, 2015
Study Start
May 21, 2015
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
June 17, 2020
Record last verified: 2020-06