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

An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00577109

Enrollment

Registered

2007-12-19

Start date

2007-12-31

Completion date

2012-06-30

Last updated

2018-07-31

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 single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is \<100 individuals.

Interventions

DRUGbevacizumab [Avastin]

5mg/kg iv on day 1 of each 2 week cycle

DRUGIrinotecan

180mg/m2 iv on day 1 of each 2 week cycle

DRUGLeucovorin

200mg/m2 iv on day 1 of each 2 week cycle

DRUG5 FU

400mg/m2 iv on day 1 of each 2 week cycle

DRUGCetuximab

Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle

Study design

Allocation

Intervention model

SINGLE_GROUP

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; * colorectal cancer; * advanced or recurrent disease; * \>=1 measurable lesion; * \>=6 months since prior adjuvant therapy, and \>=4 weeks since prior radiotherapy.

Exclusion criteria

* previous treatment for colorectal cancer; * significant history of cardiac disease in past 6 months; * other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate cancer.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	12 months

Secondary

Measure	Time frame
Objective response rate, rate of resection of hepatic metastases, overall survival.	Event driven
AEs, laboratory parameters.	Throughout study

Countries

Brazil

Outcome results

None listed

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