Study to Evaluate the Effects of Sorafenib if Combined With Chemotherapy (FOLFOX6 or FOLFIRI) in the Second-Line Treatment of Colorectal Cancer

Sponsor
AIO-Studien-gGmbH
Study ID
NCT00889343
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Sorafenib — DRUG
    2x200 mg filmcoated tablets BID on day 2-12 of a 14-days cycle, oral
  • Placebo — DRUG
    2 filmcoated tablets BID, day 2-12 of a 14-days cycle, oral
  • Oxaliplatin or Irinotecan — DRUG
    Oxaliplatin 100 mg/m2 intravenous infusion on day 1 of 14-days cycle, Irinotecan 180 mg/m2 intravenous infusion on day 1 of 14-days cycle
  • Leucovorin — DRUG
    400 mg/m2 intravenous infusion on day 1 of a 14-days cycle
  • 5-Fluorouracil — DRUG
    400 mg/m2 intravenous bolus infusion on day 1, 2400 mg/m2 46 hour intravenous infusion on day 1 to 2 of a 14-days cycle

Study Details

The purpose of this study is to determine whether sorafenib in combination with chemotherapy has a positive effect on time to progression of the tumor or death for the treatment of large bowel cancer that has already progressed during a first chemotherapy.

Key Dates

Start date
Mar 31, 2009
Status verified
Mar 2013
Primary completion
Nov 30, 2011
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: 1
  • Placebo Comparator: 2

Primary Outcome Measure

To compare the PFS between patients receiving chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib with chemotherapy + placebo [ Time Frame: 6 to 12 months ]

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