Multicenter randomized phase III study of adding Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced colorectal cancer who have failed prior Bevacizumab plus Oxaliplatin-based therapy.

Multicenter randomized phase III study of adding Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced colorectal cancer who have failed prior Bevacizumab plus Oxaliplatin-based therapy. - Phase III study of Bevacizumab 5mg/kg or 10mg/kg to FOLFIRI in advanced CRC who have failed prior Bevacizumab plus Oxaliplatin-based therapy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002557

Enrollment

370

Registered

2009-09-30

Start date

2009-10-01

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

advanced colorectal cancer

Interventions

FOLFIRI plus bevacizumab 5mg/kg is treated until progression. FOLFIRI plus bevacizumab 10mg/kg is treated until progression.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Disease progression(PD) or difficult to continue for other reason after chemotherapy with bevacizumab as 1st line Oxaliplatin containing regimen (with measurable lesions in RECIST criteria) (2) Oxaliplatin and bevacizumab were administrated for more than 4 times in 1stline (3) Colorectal cancer, cytologically and/or histrogically (4) Written informed consents (5) Age: 20 years old and above (6) Performance Status(ECOG):0~1 (7) Life expectancy estimated >= 3 months (8) Sufficient organ functions

Exclusion criteria

Exclusion criteria: (1) Previously irinotecan treatment (2) Administering transfusion/ hematopoietic factor or antithrombotic drug within 14 days (3) Serious renal dysfunction (4) Serious drug hypersensitivity or a history of drug allergy (5) Active concomitant malignancy (6) Active infections (7) Symptomatic or asymptomatic but treated heart disease (8) History of thrombosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema (9) Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer (10) Pleural effusion, peritoneal fluid and pericardial fluid (11) Symptomatic brain metastasis (12) History of mental disturbances or cerebrovascular accident (13) High blood pressure and diabetic that cannot be controlled (14) Uncontrolled diarrhea (15) Serious non-healing wound and/or major surgical procedure within 4weeks prior to enroll in this study (16) Traumatic fracture of unrecovery (17) Bleeding tendency and anti-platelets therapy (including aspirin and NSAIDS) (18) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers (19) Need to treatment with atazanavir sulfate (20) Paralyzed bowel (21) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
>Overall survival >Overall survival from first line Second progression free survival (progression free survival from first line) >Response rate >Time to treatment failure >Safety	—

Countries

Japan

Contacts

Public ContactChigusa Abe

Epidemiological and Clinical research Information Network (ECRIN) Data Center

chigusa.abe@ecrin.or.jp075-762-1227

Outcome results

None listed

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