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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

Primary Purpose

Colorectal Neoplasms

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bevacizumab

Oxaliplatin

Capecitabine

Irinotecan

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring NSABP, bevacizumab, capecitabine, oxaliplatin, irinotecan, rectal cancer, colon cancer, colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NSABP Operations Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

One-year Progression-free Survival (PFS)

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.

Secondary Outcome Measures

Objective Response Rate

Toxicity - Adverse Events

Overall Survival

Duration of Response

Full Information

NCT ID

NCT00314353

First Posted

April 11, 2006

Last Updated

October 4, 2021

Sponsor

NSABP Foundation Inc

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00314353

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

Study Start Date

March 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NSABP Foundation Inc

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms

Keywords

NSABP, bevacizumab, capecitabine, oxaliplatin, irinotecan, rectal cancer, colon cancer, colorectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

130 mg/m2 IV Day 1 every 21 days for eight cycles

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Other Intervention Name(s)

Camptosar

Intervention Description

200 mg/m2 IV Day 1 every 21 days for eight cycles

Primary Outcome Measure Information:

Title

One-year Progression-free Survival (PFS)

Description

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.

Time Frame

Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Secondary Outcome Measure Information:

Title

Objective Response Rate

Time Frame

Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Title

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

Title

Overall Survival

Time Frame

Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Title

Duration of Response

Time Frame

Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norman Wolmark, MD

Organizational Affiliation

NSABP Foundation Inc

Official's Role

Principal Investigator

Facility Information:

Facility Name

NSABP Operations Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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