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

Phase 2
Conditions
advanced colorectal cancer
Registration Number
JPRN-UMIN000002378
Lead Sponsor
Japan South West Oncology Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
45
Inclusion Criteria

Not provided

Exclusion 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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