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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: bevacizumab [Avastin]; Drug: Irinotecan; Drug: Leucovorin; Drug: 5 FU; Drug: Cetuximab

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Salvador, Brazil
  • Sao Paulo, Brazil
  • Sorocaba, Brazil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Merck KGaA, Darmstadt, Germany

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2007
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 18, 2007
• First Posted (Estimate): December 19, 2007

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protective Agents; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Micronutrients; Vitamins; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Bevacizumab; Leucovorin; Irinotecan; Cetuximab
• Other Study ID Numbers: ML20452