Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy

Phase 2

• Conditions: Metastatic colorectal cancer

• Registration Number: JPRN-UMIN000010319
• Lead Sponsor: Japan Clinical Cancer Research Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (2)Symptomatic brain metastases (3)Infectious disease (4)Interstitial lung disease or pulmonary fibrosis (5)Comorbidity or history of heart failure (6)History of thromboembolic events (7)History of hemoptysis (8)Sensory alteration or paresthesia interfering with function (9)Large quantity of pleural, abdominal or cardiac effusion (10)Severe comorbidity (renal failure, liver failure, hypertension, etc) (11)Prior radiotherapy for primary and metastases tumors (12)Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breast feeding. Women with a positive pregnancy test (13)History of severe allergy (14)Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 4 weeks (15)Systemic administration of antiplatelet drug or NSAIDs (16)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy (17)Uncontrolled peptic ulcer (18)History of gastrointestinal perforation within 1 year (19)Untreated traumatic bone fracture (20)Require treatment of renal dysfunction (21)Doubting dihydropyrimidine dehydrogenase deficit (22) Uncontrolled diarrhea (23)History of organ recipient (24)Administration of atazanavir sulfate (25Administration of flucytosine (26)Jaundice (27) Ileus or bowel obstruction (28)Any other cases who are regarded as inadequate for study enrollment by investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-Month Progression Free Survival Rate

Secondary Outcome Measures

Name	Time	Method
Overall Survival Progression Free Survival Response Rate Safety