Clinical trial · Interventional

Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer

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

NCT02497157CI-TRIAL-00045585BeTRIcompletedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Metastatic Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Bevacizumab (Bmab)	Drug	Bevacizumab	ALIAS
Continuous intravenous infusion of fluorouracil (CIV 5-FU)	Drug	—	UNRESOLVED
Irinotecan hydrochloride hydrate (CPT-11)	Drug	Irinotecan	ALIAS
Levofolinate calcium (l-LV)	Drug	Levoleucovorin	ALIAS
Oxaliplatin (L-OHP)	Drug	Oxaliplatin	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment Arm
description
Patients 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.
interventionNames
1. Drug: Oxaliplatin (L-OHP)
2. Drug: Irinotecan hydrochloride hydrate (CPT-11)
3. Drug: Continuous intravenous infusion of fluorouracil (CIV 5-FU)
4. Drug: Levofolinate calcium (l-LV)
5. Drug: Bevacizumab (Bmab)

Primary outcomes (1)

measure
Response rate (RR) by response evaluation criteria in solid tumors (RECIST v1.1)
timeFrame
Up to 18 months
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 20 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the colon or rectum.
2. Unresectable or recurrent colorectal cancer patient.
3. One or more measurable lesion in RECIST ver.1.1 criteria.
4. No prior chemotherapy, immunotherapy, and radiotherapy.
5. Life expectancy at least 3 months.
6. Patients who harbor UGT1A1\*1/\*1, \*1/\*6 or \*1/\*28.
7. The Eastern Cooperative Oncology Group (ECOG) performance status of =\<1.
8. 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
9. Written informed consent.

Exclusion Criteria:

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: May 21, 2015
Primary completion: Jun 1, 2019
Completion: Jun 1, 2019
First posted: Jul 14, 2015
Last update posted: Jun 17, 2020
Enrollment: 45 (estimated)
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan OTHER
Collaborators: Hiroshima Prefectural Hospital; National Hospital Organization Shikoku Cancer Center
Keywords: bevacizumab, oxaliplatin, irinotecan, hydrochloride hydrate, fluorouracil, levofolinate calcium

Data updated 22 days agoSource updated Jun 17, 2020source: clinicaltrials

Locations

Locations by country (7)

Country	Sites	Recruiting
Japan	7	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.