Analysis of pharmacokinetics and pharmacodynamics for capecitabine during new chemotherapy regimen by bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer

Analysis of pharmacokinetics and pharmacodynamics for capecitabine during new chemotherapy regimen by bevacizumab (Bev) in combination with XELOX in unresectable colorectal cancer - Analysis of pharmacokinetics and pharmacodynamics for Capecitabine during new chemotherapy regimen

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013038

Enrollment

Registered

2014-02-01

Start date

2014-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable colorectal cancer

Interventions

Measurement ofcapecitabin metabolism during XELOX+BV 5-days on/ 2-days off schedule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.informed consent 2.more than 20 yeras old 3.ECOG Performance Status 0-2 4.survival more than 3 months 5.histopathological colorectal cancer 6.measurable lesion as RECIST Ver 1.1 7.first or first recurrent colorectal cancer 8.WBC more than 3000/mm3, neutrophil more than 1500/mm3, Platelet more than 10x104/mm3, Hb more than 9g/dL, TBil less than 1.5mg/dL, AST and ALT and ALP less than 100IU/L (with liber metastasis less than 200IU/L) , Cr less than 1.5mg/dL, urinary protein 1+

Exclusion criteria

Exclusion criteria: 1.Treatment for ascites and thoracic effusion is needed. 2.There is brain tumor or brain metastasis. 3.Untreated double cancer within 5 years 4.There is cerebrovascular disease 5.surgery within 4 weeks 6.surgery for study 7.use of drug effected for blood coagulation system 8.Bleeding tendency 9.Uncontrorable peptic ulcer 10.gastrointestinal perforation within 6 months 11.untreated fructure 12.renal failure 13.Uncontrorable hypertension 14.Uncontrorable diabetes meritus 15.heart disease 16.hypersensitivity for fluorouracil and platinum 17.DPD defect 18.Uncontrorable diarrhea 19.interstitial pneumonia or pulmonary fibrosis 20.organ transplant needed immunosuppressant drug 21.Uncontrorable infectious disease 22.similarterm for BV treatment 23.difficult for oral intake

Design outcomes

Primary

Measure	Time frame
Confirmation for PK/PD analysis of capecitabine	—

Countries

Japan

Contacts

Public ContactTsukasa Hotta

Wakayama Medical University, School of Medicine Second Department of Surgery

hotta@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026