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

Phase 2

Terminated

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Irinotecan

• Registration Number: NCT00314353
• Lead Sponsor: NSABP Foundation Inc

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-13
• Primary Completion: 2008-05
• Results First Submitted: 2008-11-07
• Results First Submitted QC: 2008-12-01
• Results First Posted: 2008-12-02
• Study Completion: 2010-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Oxaliplatin	-
1	Bevacizumab	-
1	Capecitabine	-
2	Bevacizumab	-
2	Capecitabine	-
2	Irinotecan	-

Primary Outcome Measures

Name	Time	Method
One-year Progression-free Survival (PFS)	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Toxicity - Adverse Events	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	Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Duration of Response	Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Trial Locations

Locations (1)

NSABP Operations Center; 🇺🇸 Pittsburgh, Pennsylvania, United States