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Clinical Trials List

Protocol NumberD8480C00013
NCT Number(ClinicalTrials.gov Identfier)NCT00384176

2008-03-20 - 2011-01-31

Phase III

Terminated4

ICD-10C18.9

Malignant neoplasm of colon, unspecified

A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTINTM, AZD2171) in Combination with 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination with FOLFOX in Patients with Previously Untreated Metastatic Colorectal Cancer

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    AstraZeneca AB

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Tsai-Sheng Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chueh-Chuan Yen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Wu-Chou Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 黃敬倫 Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Colorectal Cancer

Objectives

The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.

Test Drug

AZD2171

Active Ingredient

Cediranib

Dosage Form

tablet

Dosage

15, 20

Endpoints

Primary Outcome Measures: Progression Free Survival

Secondary Outcome Measures:
1.Overall Survival
2.Objective Response Rate
3.Duration of Response
4.Percentage Change in Tumour Size
5.Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)

Inclution Criteria

1.Clinical Diagnosis of colon or rectal cancer
2.No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry.

Exclusion Criteria

1.Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.
2.Poorly controlled hypertension

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    1600 participants

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