Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

Sponsor
Chugai Pharmaceutical
Study ID
NCT00345761
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
  • Oxaliplatin — DRUG
    130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
  • Capecitabine — DRUG
    2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Study Details

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.

Key Dates

First listed
Jun 28, 2006
Start date
Feb 28, 2006
Status verified
Aug 2010
Primary completion
Oct 31, 2008
Completion
Jul 31, 2010

Study Design

Enrollment
64 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Step 1
  • Experimental: Step 2
  • Experimental: Step 3

Primary Outcome Measure

Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: event driven ]

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