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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00642577

Enrollment

214

Registered

2008-03-25

Start date

2007-07-31

Completion date

2010-12-31

Last updated

2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DRUGbevacizumab [Avastin]

5mg/kg iv every 2 weeks

DRUGirinotecan

125mg/m2 iv weekly for 4 weeks of each 6 week cycle

DRUGleucovorin

20mg/m2 iv weekly for 4 weeks of each 6 week cycle

DRUGfluorouracil

500mg/m2 iv weekly for 4 weeks of each 6 week cycle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival.	6 months

Secondary

Measure	Time frame
Overall response rate, time to response, duration of response, overall survival.	Event driven
AEs, laboratory tests	Throughout study

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026