Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

NCT00345761 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2010-08-16

No results posted yet for this study

Summary

This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth \[po\], day 1 pm-day 15 am every 3 weeks \[q3w\]), oxaliplatin (130 mg/m2 intravenously \[iv\], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Conditions

Interventions

DRUG

Bevacizumab

7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)

DRUG

Oxaliplatin

130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)

DRUG

Capecitabine

2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Sponsors & Collaborators

  • Yakult Honsha Co., LTD

    collaborator INDUSTRY
  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Yuji Hayashi · Clinical Development Department 3, Group 6

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-10-31
Completion
2010-07-31

Countries

  • Japan

Study Locations

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Entities

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 NCT00345761 on ClinicalTrials.gov