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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

One-year Progression-free Survival (PFS)

Outcome 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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

NSABP FC-BV-003

NCT ID:

NCT00314353

Start Date:

March 2006

Completion Date:

June 2010

Related Keywords:

  • Colorectal Neoplasms
  • NSABP
  • bevacizumab
  • capecitabine
  • oxaliplatin
  • irinotecan
  • rectal cancer
  • colon cancer
  • colorectal cancer
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

NSABP Operations CenterPittsburgh, Pennsylvania  15212