Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon

October 4, 2021 updated by: NSABP Foundation Inc

Randomized Phase II Clinical Trial of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Line Treatment for Metastatic Colorectal Cancer

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • NSABP Operations Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum)
  • Evidence of adequate organ function (such as liver, kidneys, etc.)

Exclusion Criteria:

  • Diagnosis of anal cancer
  • Patients who are candidates for surgery
  • Patients who have received previous treatments
  • Pregnant or lactating women
  • History of chronic disease(s) or other serious medical conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Bevacizumab

7.5 mg/kg IV Day 1 every 21 days for eight cycles*

*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.

Other Names:
  • Avastin
Drug: Oxaliplatin
130 mg/m2 IV Day 1 every 21 days for eight cycles
Other Names:
  • Eloxatin
Drug: Capecitabine

850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*#

*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression.

#For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID

Other Names:
  • Xeloda
Experimental: 2
Drug: Bevacizumab

7.5 mg/kg IV Day 1 every 21 days for eight cycles*

*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.

Other Names:
  • Avastin
Drug: Capecitabine

850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*#

*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression.

#For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID

Other Names:
  • Xeloda
Drug: Irinotecan
200 mg/m2 IV Day 1 every 21 days for eight cycles
Other Names:
  • Camptosar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year Progression-free Survival (PFS)
Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Toxicity - Adverse Events
Time Frame: Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab
Overall Survival
Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Duration of Response
Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NSABP Foundation Inc

Collaborators

Hoffmann-La Roche
Genentech, Inc.
International Drug Development Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 13, 2006

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSABP FC-BV-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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