Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)

Sponsor
AstraZeneca
Study ID
NCT00278889
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD2171 — DRUG
    oral tablet
  • 5-fluorouracil — DRUG
    intravenous infusion
  • Leucovorin — DRUG
    intravenous infusion
  • Oxaliplatin — DRUG
    intravenous infusion
  • Bevacizumab — DRUG
    intravenous infusion

Study Details

The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

Key Dates

First listed
Jan 19, 2006
Start date
Jan 31, 2006
Status verified
Sep 2012
Primary completion
Nov 30, 2007
Completion
Oct 31, 2009

Study Design

Enrollment
215 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Bevacizumab + FOLFOX
  • Experimental: 2
    AZD2171 + FOLFOX

Primary Outcome Measure

Progression Free Survival [ Time Frame: Randomisation to data cut-off date of November 2007 ]

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