A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.
Primary Purpose
Colorectal Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
bevacizumab [Avastin]
Irinotecan
Leucovorin
5 FU
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Objective response rate, rate of resection of hepatic metastases, overall survival.
AEs, laboratory parameters.
Full Information
NCT ID
NCT00577109
First Posted
December 18, 2007
Last Updated
July 27, 2018
Sponsor
Hoffmann-La Roche
Collaborators
Merck KGaA, Darmstadt, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00577109
Brief Title
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study was cancelled before patient enrollment
Study Start Date
December 2007 (Anticipated)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Merck KGaA, Darmstadt, Germany
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
5mg/kg iv on day 1 of each 2 week cycle
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
180mg/m2 iv on day 1 of each 2 week cycle
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
200mg/m2 iv on day 1 of each 2 week cycle
Intervention Type
Drug
Intervention Name(s)
5 FU
Intervention Description
400mg/m2 iv on day 1 of each 2 week cycle
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Objective response rate, rate of resection of hepatic metastases, overall survival.
Time Frame
Event driven
Title
AEs, laboratory parameters.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Salvador
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Sorocaba
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.
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