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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00577109
Recruitment Status : Withdrawn (Study was cancelled before patient enrollment)
First Posted : December 19, 2007
Last Update Posted : August 24, 2016
Merck KGaA
Information provided by:
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: bevacizumab [Avastin] Drug: Irinotecan Drug: Leucovorin Drug: 5 FU Drug: Cetuximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Objective response rate, rate of resection of hepatic metastases, overall survival. [ Time Frame: Event driven ]
  2. AEs, laboratory parameters. [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00577109

Salvador, Brazil
Sao Paulo, Brazil
Sorocaba, Brazil
Sponsors and Collaborators
Hoffmann-La Roche
Merck KGaA
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche Identifier: NCT00577109     History of Changes
Other Study ID Numbers: ML20452
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action