Phase 2 study of bevacizumab and irinotecan as second-line therapy in patients with advanced colorectal cancer previously treated with oxaliplatin and bavacizumab

Phase 2 study of bevacizumab and irinotecan as second-line therapy in patients with advanced colorectal cancer previously treated with oxaliplatin and bavacizumab - Bevacizumab Beyond Progression Plus Irinotecan trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007065

Enrollment

Registered

2012-01-16

Start date

2012-01-01

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

Bevacizumab+Irinotecan Bevacizumab: 10mg/kg d.i.v. day1 Irinotecan:150mg/m2 d.i.v.day1 to be repeated every 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Disease progression after chemotherapy with bevacizumab as 1st-Line Oxaliplatin containing regimen (2)Oxaliplatin and bevacizumab were administrated for more than 4 times in 1st-Line (3)Difficult to continue 5FU treatment (4)Colorectal cancer,cytologically and/or histrogically (5)Written informed consents (6)Age:20 years old and above (7)Eastern Cooperative Oncology Group (ECOG) perormance status 0-2 (8)Life expectancy estimated over 3 months (9)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)Uncontrolled infection (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 (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 Response Rate Progression free survival according to K-ras status Overall survival according to K-ras status Frequency of adverse events	—

Countries

Japan

Outcome results

None listed

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