Multicenter Phase II Study of XELOX with Bevacizumab in the Late Elderly Patients with Unresectable Advanced/Recurrent Colorectal Cancer

Phase 2

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000003500
• Lead Sponsor: Epidemiological and Clinical Research Information Network (ECRIN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-16
• Study Completion: 2013-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1)Uncontrolled pleural effusion or ascites. 2)Brain metastasis. 3)Other active malignancies or a history of other malignancies within the past 5 years. 4)Clinically problematic cerebrovascular disease or arterial thromboembolism, or history of cerebrovascular disease or arterial thromboembolism within the past 1 year. 5)Surgery, biopsy specimen with section or sutures within the past 4 weeks. Fine needle aspiration biopsy within 1 week. 6)Planning of surgery during the trial. 7)Clotting drug use within the past 10 days. 8)Bleeding tendency. 9)Uncontrolled peptic ulcer. 10)Perforation of the digestive tract or history of the perforation of the digestive tract within the past 6 months. 11)Untreated traumatic bone fracture. 12)Nephropathy that requires medication or transfusion or urine protein over +2 within 2 weeks examination. 13)Uncontrolled hypertension. 14)Uncontrolled diabetes mellitus. 15)Clinically problematic cardiac disease (grade 2 or more, based on Common Toxicity Criteria for Adverse Events [CTCAE] ver.4.0 within the past 12 months). 16)History of hypersensitivity against fluorouracil or platinum agents. 17)History of the adverse events related to dihydropyrimidine dehydrogenase deficiency against fluorinated pyrimidines. 18)Uncontrolled diarrhea. 19)Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.). 20)Organ transplant that requires any immunosuppressant. 21)Uncontrolled infection. 22)History of bevacizumab use. 23)Unable to intake orally. 24)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
Toxicity ORR; overall response rate TTF; time to treatment failure OS; overall survival