Phase III Randomized Study of 5-FU, CoFactor, and Avastin vs. 5-FU, LV and Avastin for First-Line Colorectal Cancer.

Part of paid clinical trials in Florence, Alabama.

Sponsor
Mast Therapeutics, Inc.
Study ID
NCT00337389
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • 5- Fluorouracil (5-FU) — DRUG
  • bevacizumab (Avastin) — DRUG
  • Leucovorin — DRUG
  • CoFactor (ANX-510) — DRUG

Study Details

To compare the progression-free survival time (PFS) in patients treated with 5-FU modulated with CoFactor (plus bevacizumab) to 5-FU modulated with leucovorin (plus bevacizumab) in patients with Metastatic Colorectal Cancer.

Key Dates

First listed
Jun 16, 2006
Start date
May 31, 2006
Status verified
Nov 2007

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    CoFactor, 5-FU, Avastin
  • Active Comparator: 2
    Leucovorin, 5-FU, Avastin

Primary Outcome Measure

Progression Free Survival

Locations (46)

FacilityCityStateZIPSite coordinators
Research Center InFlorenceAlabama--
Research Center InAnaheimCalifornia--
Research Center InApple ValleyCalifornia--
Research Center InBeverly HillsCalifornia--
Research Center InIrvineCalifornia--
Research Center InMission HillsCalifornia--
Research Center InPowayCalifornia--
Research Center InRancho MirageCalifornia--
Mercy General HospitalSacramentoCalifornia95819-
Research Center InSacramentoCalifornia--
Research Center InSan DiegoCalifornia--
Research Site InSan DiegoCalifornia--
Research Center InVistaCalifornia--
Research Center InBoynton BeachFlorida--
Research Center InMerritt IslandFlorida--
Research Center InPort Saint LucieFlorida--
Research Center InTarpon SpringsFlorida--
Research Center InGurneeIllinois--
Research Center InJolietIllinois--
Research Center InSkokieIllinois--
Research Center InIndianapolisIndiana--
Research Center InWichitaKansas--
Research Center InHazardKentucky--
Research Center InBaltimoreMaryland--
Research Center InFlintMichigan--
Research Center InFree SoilMichigan--
Research Center InGrand RapidsMichigan--
Research Center InPort HuronMichigan--
Research Center InJacksonMississippi--
Research Center InHendersonNevada--
Research Center InLas VegasNevada--
Research Center InRenoNevada--
Research Center InCherry HillNew Jersey--
Research Center InFarmingtonNew Mexico--
Research Center InEast SetauketNew York--
Research Center InGreenvilleNorth Carolina--
Research Center InMiddletownOhio--
Research Center InCranstonRhode Island--
Research Center InCharlestonSouth Carolina--
Research Center InColumbiaSouth Carolina--
Research Center InChattanoogaTennessee--
Research Center InColliervilleTennessee--
Research Center InFort WorthTexas--
Research Center InOgdenUtah--
Research Center InLaceyWashington--
Research Center InWalla WallaWashington--

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