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

NCT ID: NCT00577109

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-06-30

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type: DRUG

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

Irinotecan

Intervention Type: DRUG

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

Leucovorin

Intervention Type: DRUG

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

5 FU

Intervention Type: DRUG

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

Cetuximab

Intervention Type: DRUG

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

Interventions

bevacizumab [Avastin]

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

Intervention Type: DRUG

Irinotecan

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

Intervention Type: DRUG

Leucovorin

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

Intervention Type: DRUG

5 FU

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

Intervention Type: DRUG

Cetuximab

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Salvador, , Brazil

São Paulo, , Brazil

Sorocaba, , Brazil

Countries

Brazil

Other Identifiers

ML20452

Identifier Type: -

Identifier Source: org_study_id