A Phase I /II Study of Tri-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.

A Phase I /II Study of Tri-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy. - BIX study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003482

Enrollment

Registered

2010-04-13

Start date

2010-05-01

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

colorectal cancer

Interventions

XELIRI+ bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Written informed consent (2) Age: 20-75 years old. (3)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. (4) Life expectancy greater than or equal to 3 months (5)Histological confirmation of colorectal cancer. (6) unresectable primary tumor or with one or more unresectable metatatic tumor Measurable or evaluable disease (measurable lesions in RECIST criteria is unnecessary) (7) Progression during or after first-line chemotherapy for metastatic disease, including Oxaliplatin-based chemotherapy with bevacizumab (8) Vital organ functions (listed below) are preserved within 2 weeks prior to entry i. Neurtophils >= 1,500/mm3 ii. Platelets >= 100,000/mm3 iii. Hemoglobin >= 9.0g/dl iv. Total bilirubin <= 1.5ml/dl v. AST and ALT <= 100IU/l (200IU/L in case of liver metastasis) vi. Serum creatinine <= 1.5mg/dl vii.Patients with UGT1A1 genotype wild type and *6,*28 heterozygote

Exclusion criteria

Exclusion criteria: (1) Treatment with tegafur gimestat otastat potassium Within 7 days (2) Need to drain malignant coelomic fluid. (3)Jaundice (4)Paralytic or mechanical bowel obstruction (5)Receiving Atazanavir Sulfate (6)Radiological evidence of CNS metastases or brain cancer (7) Multiple primary cancer within 5 years. (8) Complication of cerebrovascular disease or symptoms within 1 year. (9) Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. (10) Administering antithrombotic drug within 10 days. (11) Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS) (12) Evidence of bleeding diathesis or coagulopathy. (13)Active gastrointestinal ulcer (14) Current or previous (within the last 1 year) history of GI perforation (15)Non healing fracture (16)Renal failure to be treated, 3+ or higher proteinuria within 2 weeks prior to entry (17)Uncontrolled Hypertension (18)Uncontrolled diabetes mellitus (19)Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction (20)History of the serious hypersensitivity for Fluorouracil or bevacizumab (21)Evidence of interstinal lung disease, or pulmonary fibrosis (22)History of organ transplantation (23) Treatment history of irinotecan (24) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Phase I part Estimated the dose limiting toxicities in 1st cycle. Phase II part Progressiom Free Survival	—

Secondary

Measure	Time frame
Phase II Safety response rate	—

Countries

Japan

Contacts

Public ContactYasuhide Yamada/Takako nakajima

National Cancer Center Central hospital Department of Gastroenterology

03-3542-2511

Outcome results

None listed

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