Back to resultsA Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
bevacizumab [Avastin]
irinotecan
leucovorin
fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease;
- >=1 measurable lesion;
- ECOG performance status of <=1.
Exclusion Criteria:
- prior systemic therapy for advanced or metastatic disease;
- adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
- other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
- clinically significant cardiovascular disease in past 6 months.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival.
Secondary Outcome Measures
Overall response rate, time to response, duration of response, overall survival.
AEs, laboratory tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00642577
Brief Title
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.
Official Title
A Randomized, Open Label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Irinotecan + 5-fluorouracil/Folinic Acid, and Irinotecan + 5-fluorouracil/Folinic Acid Alone, on Progression-free Survival in Chinese Patients With Metastatic Colorectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
5mg/kg iv every 2 weeks
Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Description
125mg/m2 iv weekly for 4 weeks of each 6 week cycle
Intervention Type
Drug
Intervention Name(s)
leucovorin
Intervention Description
20mg/m2 iv weekly for 4 weeks of each 6 week cycle
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Description
500mg/m2 iv weekly for 4 weeks of each 6 week cycle
Primary Outcome Measure Information:
Title
Progression-free survival.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall response rate, time to response, duration of response, overall survival.
Time Frame
Event driven
Title
AEs, laboratory tests
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease;
>=1 measurable lesion;
ECOG performance status of <=1.
Exclusion Criteria:
prior systemic therapy for advanced or metastatic disease;
adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
clinically significant cardiovascular disease in past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Beijing
ZIP/Postal Code
100021
Country
China
City
Beijing
ZIP/Postal Code
100036
Country
China
City
Beijing
ZIP/Postal Code
100071
Country
China
City
Chongqing
ZIP/Postal Code
400042
Country
China
City
Guangdong
ZIP/Postal Code
510515
Country
China
City
Guangzhou
ZIP/Postal Code
510060
Country
China
City
Nanjing
ZIP/Postal Code
210002
Country
China
City
Qingdao
ZIP/Postal Code
266003
Country
China
City
Shanghai
ZIP/Postal Code
200003
Country
China
City
Shanghai
ZIP/Postal Code
200080
Country
China
City
Tianjin
ZIP/Postal Code
300060
Country
China
City
Wuhan
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.
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