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Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer

NCT00416494 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-09-03

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab works in treating patients with metastatic or recurrent colorectal cancer.

Conditions

Interventions

BIOLOGICAL

bevacizumab

10 mg/kg intravenously over 30-90 minutes on day 1

DRUG

oxaliplatin

85 mg/m2 intravenously over 2 hours on day 1.

DRUG

Capecitabine

Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort

DRUG

Capecitabine

Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Herbert Hurwitz, MD

    lead OTHER

Principal Investigators

  • Herbert I. Hurwitz, MD · Duke Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2008-01-31
Completion
2014-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00416494 on ClinicalTrials.gov