Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer

Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer - Phase II study of chemotherapy with Capecitabine/Bevacizumab in elderly patients with advanced and recurrent colorectal cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010200

Enrollment

Registered

2013-03-11

Start date

2012-09-07

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

advanced and/or recurrent colorectal cancer

Interventions

Capecitabine plus bevacizumab therapy Capecitabine:2,000mg/m2 twice daily (orally, day1 after dinner:day8 after breakfast) Bevacizumab:7.5mg/kg day 1 The treatment is repeated every three weeks unt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)histologically confirmed colorectal cancer (2)Advanced or recurrent colorectal cancer that is first line chemotherapy (3)Age of 70 years or older (4)Measurable or evaluable disease (RECIST ver.1.1.) (5)ECOG performance status of 0-2 (6)Life expectancy more than 3 months (7)Adequate organ functions Neutrophil: => 1500/mm3 Platelet: => 100,000/mm3 Hemoglobin concentration: => 9.0g/dl Total bilirubin: <= 1.5mg/dl AST or ALT: <= 100IU/I Cr: <= 1.2mg/dl proteinuria: <= 1+ (8) Written informed consent after the explanation of the content of the examination

Exclusion criteria

Exclusion criteria: (1)active brain metastases (2) Complication of cerebrovascular disease or symptoms within 1 year (3) Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week (4) History of gastrointestinal perforation within 1 year. (5) Uncontrollable peptic ulcer, Hypertension, diarrhea, infections (6) A bleeding tendency, coagulation disorder or abnormal coagulation factor (7) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day) (8) Serious heart disease (9) History of active double cancer within 5 years (10)History of the serious hypersensitivity for capecitabine or bevacizumab (11)Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Overall Survival,Response rate,Disease Contorol Rate,Safty	—

Countries

Japan

Contacts

Public ContactTadahiko Enoki

Yamafuchi University Medical Bioregulation Department of Organ Regulatory Surgery

Outcome results

None listed

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