A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Bevacizumab; Drug: Fluoropyrimidine-based Chemotherapy

• Registration Number: NCT01169558
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Results First Submitted: 2016-08-25
• Results First Submitted QC: 2016-08-25
• Status Verified: 2016-10
• Results First Posted: 2016-10-18
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Previously untreated metastatic colon or rectal cancer;
• Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.

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Exclusion Criteria

• Prior chemotherapy for metastatic colon or rectal cancer;
• Planned radiotherapy for underlying disease;
• central nervous system metastases;
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Fluoropyrimidine-based Chemotherapy	Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
Bevacizumab	Bevacizumab	Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.

Primary Outcome Measures

Name	Time	Method
Safety: Number of Participants With Serious and Specific Adverse Events	Up to approximately 3 years	A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.

Secondary Outcome Measures

Name	Time	Method
Efficacy: Overall Survival	Up to approximately 3 years	Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival.
Efficacy: Progression-free Survival	Up to approximately 3 years	Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Reported is the median time of PFS.
Efficacy: Time to Disease Progression	Up to approximately 3 years	Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression.