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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

N

National Surgical Adjuvant Breast and Bowel Project Foundation (NSABP)

Status and phase

Terminated
Phase 2

Conditions

Colorectal Neoplasms

Treatments

Drug: Bevacizumab
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Irinotecan

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT00314353
NSABP FC-BV-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: Bevacizumab
Drug: Oxaliplatin
Drug: Capecitabine
2
Experimental group
Treatment:
Drug: Bevacizumab
Drug: Irinotecan
Drug: Capecitabine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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