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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00577109
Other study ID # ML20452
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date December 2007
Est. completion date June 2012

Study information

Verified date August 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
bevacizumab [Avastin]
5mg/kg iv on day 1 of each 2 week cycle
Irinotecan
180mg/m2 iv on day 1 of each 2 week cycle
Leucovorin
200mg/m2 iv on day 1 of each 2 week cycle
5 FU
400mg/m2 iv on day 1 of each 2 week cycle
Cetuximab
Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Hoffmann-La Roche Merck KGaA

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival 12 months
Secondary Objective response rate, rate of resection of hepatic metastases, overall survival. Event driven
Secondary AEs, laboratory parameters. Throughout study
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