Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Metastatic Pancreatic Cancer

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
Eli Lilly and Company
Study ID
NCT00326911
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • cetuximab — BIOLOGICAL
    I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1
  • bevacizumab — BIOLOGICAL
    10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.
  • gemcitabine — DRUG
    1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks.
  • cetuximab — BIOLOGICAL
    I.V.infusions of 250 mg/m2 (over 60 minutes) weekly

Study Details

Eligible patients with metastatic pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine

Key Dates

First listed
May 17, 2006
Start date
May 31, 2006
Status verified
May 2011
Primary completion
Oct 31, 2008
Completion
Dec 31, 2008

Study Design

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

Arms

  • Experimental: cetuximab + bevacizumab + gemcitabine
    Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. All medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
  • Active Comparator: cetuximab + bevacizumab
    Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Time from randomization to disease progression or death from any cause (Range: 0 -10 months) ]

Locations (16)

FacilityCityStateZIPSite coordinators
ImClone Investigational SiteJonesboroArkansas72401-
ImClone Investigational SiteSan FranciscoCalifornia94115-
ImClone Investigational SiteStamfordConnecticut06902-
ImClone Investigational SiteMiamiFlorida33176-
ImClone Investigational SiteOrlandoFlorida32804-
ImClone Investigational SiteOrlandoFlorida32806-
ImClone Investigational SiteAtlantaGeorgia30309-
ImClone Investigational SiteAugustaGeorgia30901-
ImClone Investigational SiteMariettaGeorgia30060-
ImClone Investigational SiteMetairieLouisiana70006-
ImClone Investigational SiteBillingsMontana59101-
ImClone Investigational SiteConcordNorth Carolina28025-
ImClone Investigational SitePhiladelphiaPennsylvania19106-
ImClone Investigational SiteCharlestonSouth Carolina29406-
ImClone Investigational SiteArlingtonTexas76012-
ImClone Investigational SiteDallasTexas75230-

Find similar trials in Jonesboro, AR

By research site
ImClone Investigational Site· Jonesboro, ARImClone Investigational Site· San Francisco, CAImClone Investigational Site· Stamford, CTImClone Investigational Site· Miami, FLImClone Investigational Site· Orlando, FLImClone Investigational Site· Atlanta, GA

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