Safety and efficacy of FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab as second line Therapy in Advanced colorectal Cancer previously treated with bevacizumab.

UMIN ID: UMIN000002378

Registered date:28/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced colorectal cancer
• Date of first enrollment: 2009/01/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab is treated until progression.

Outcome(s)

• Primary Outcome: progression free survival
• Secondary Outcome: .Overall survival from first line .Second progression free survival (progression free survival from first line) .Response rate .Time to treatment failure .Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (1) Administering transfusion/hematopoietic factor or antithrombotic drug within 14 days (2) Serious renal complications (3) Serious drug hypersensitivity or a history of drug allergy (4) Peripheral neuropathy (5) Active concomitant malignancy (6) Active infections (7) High blood pressure and diabetic that cannot be controlled (8) symptomatic or asymptomatic but treated heart disease (9) interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema (10) Traumatic fracture of unrecovery (11) history of mental disturbances or cerebrovascular accident (12) Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer (13) Current or previous (within one year) history of GI perforation (14) Pleural effusion, peritoneal fluid and pericardial fluid (15) Symptomatic brain metastasis (16) uncontrolled diarrhea (17) Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week (18) Anti-platelets therapy (including aspirin and NSAIDS) (19) Need to treatment with atazanavir sulfate (20) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers (21) bleeding tendency(including hemoptysis) or coagulation disorder (22) Other conditions not suitable for this study

Related Information

• Primary Sponsor: Japan South West Oncology Group
• Source(s) of Monetary Support: None