Phase II study of Bevacizumab in combination with FOLFIRI as second-line therapy for patients with metastatic colorectal cancer who have progressed on Bevacizumab with Oxaliplatin-based chemotherapy

Phase II study of Bevacizumab in combination with FOLFIRI as second-line therapy for patients with metastatic colorectal cancer who have progressed on Bevacizumab with Oxaliplatin-based chemotherapy - Phase II study of Bevacizumab in combination with FOLFIRI as second-line therapy for patients with metastatic colorectal cancer who have progressed on Bevacizumab with Oxaliplatin-based chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002407

Enrollment

Registered

2009-09-01

Start date

2009-08-01

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

metastatic colorectal cancer

Interventions

Bevacizumab(10mg/kg) plus FOLFIRI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histological confirmation of colorectal cancer 2.Measurable lesion 3.documented disease progression(PD) during Bevacizumab with Oxaliplatin-based chemotherapy* or within four weeks thereafter via radiographic assessment *receipt of this regimen for at least two months 4.Age : > 20 years 5.ECOG-PS : 0-2 6.Adequate organ function before fourteen days,defined as leukocyte count >= 3000/mm3(neutrophil cell count >=1500/mm3),platelet count >= 100000/mm3,hemoglobin >=9.0g/dl,Total bilirubin <= 1.5xULN,AST/ALT/ALP <= 2.5xULN,serum creatinine <= 1.5xULN 7.Survival period more than 3 months 8.Written informed consents

Exclusion criteria

Exclusion criteria: 1.clinical or radiological evidence of CNS metastases. 2.current or previous (within the last 1 year) history of cerebrovascular disease 3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to Day 0 4.serious non-healing fracture 5.current or previous (within the last 1 year) history of GI perforation 6.serious non-healing ulcer 7.evidence of bleeding diathesis or coagulopathy. 8.current or recent (within 10 days prior to enrllment) ongoing treatment with anticoagulants for therapeutic purposes 9.ongoing treatment with aspirin (> 325 mg/day) 10.clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction 11.uncontrolled hypertension 12. serious renal failure, 1+ or higher proteinuria within 2 weeks prior to enrollment 13.uncontrolled pleural and/or peritoneal effusion 14.past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated: - Basal and squamous cell carcinoma of the skin - In-situ carcinoma of the cervix 15.interstitial lung disease, or pulmonary fibrosis 16.uncontrolled infection 17.history of organ transplantation 18.diarrhea >= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 3. 19.pregnancy (positive serum pregnancy test) and lactation 20.serious drug hypersensitivity or a history of drug allergy 21.history of adverse events related to fluorouracil 22.Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Safety,Overall response rate,Overall survival,Overall survival from 1st line	—

Countries

Japan

Contacts

Public Contactmichio nakamura

Sapporo City General Hospital Divison of Gastrointestinal Oncology and Endoscopy

Outcome results

None listed

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