A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.

Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642577
• Other study ID #: BO20696
• Status: Completed
• Phase: Phase 3
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: December 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
5mg/kg iv every 2 weeks
• irinotecan
125mg/m2 iv weekly for 4 weeks of each 6 week cycle
• leucovorin
20mg/m2 iv weekly for 4 weeks of each 6 week cycle
• fluorouracil
500mg/m2 iv weekly for 4 weeks of each 6 week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival.		6 months
Secondary	Overall response rate, time to response, duration of response, overall survival.		Event driven
Secondary	AEs, laboratory tests		Throughout study