APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Tragara Pharmaceuticals, Inc.
Study ID
NCT00709826
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • gemcitabine — DRUG
    Gemcitabine: per package insert.
  • placebo — DRUG
    placebo: 100 mg tablets, 400 mg/day
  • Erlotinib — DRUG
    Erlotinib - per package insert.
  • apricoxib — DRUG
    apricoxib: 100mg tablets, given orally

Study Details

This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.

Key Dates

First listed
Jul 3, 2008
Start date
Aug 31, 2008
Status verified
Oct 2012
Primary completion
Jun 30, 2010
Completion
May 31, 2011

Study Design

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

Arms

  • Experimental: apricoxib + gemcitabine + erlotinib
    400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
  • Placebo Comparator: placebo + gemcitabine + erlotinib
    placebo + 1000mg/m2 gemcitabine + 100mg erlotinib

Primary Outcome Measure

Progression Free Survival [ Time Frame: Randomization then every other cycle ]

Locations (39)

FacilityCityStateZIPSite coordinators
Arizona Clinical Research CenterTucsonArizona85715-
Comprehensive Blood and Cancer CenterBakersfieldCalifornia93309-
Southbay Oncology Hematology PartnersCampbellCalifornia95008-
Bay Area Cancer Research Group, LLCConcordCalifornia94523-
Bay Area Cancer Research Group, LLCPleasant HillCalifornia94523-
North America Research InstituteSan DimasCalifornia91773-
Front Range Cancer SpecialistsFort CollinsColorado80528-
Oncology Associates of BridgeportTrumballConnecticut06611-
Hematology Oncology AssociatesLake WorthFlorida33461-
Hematology Oncology Associates of Treasure CoastPort Saint LucieFlorida34952-
The Queen's Medical Center Cancer CenterHonoluluHawaii96813-
Rush-Copley Medical CenterAuroraIllinois60504-
Alexian Brothers Medical Hospital NetworkElk Grove VillageIllinois60007-
Investigative Clinical Research of Indiana, LLCIndianapolisIndiana46260-
Medical Consultants, PCMuncieIndiana47303-
University of Iowa HospitalsIowa CityIowa52242-
Owsley Brown Frazier Cancer CenterLouisvilleKentucky40245-
Jayne Gurtler, MDMetairieLouisiana70006-
Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin SquareBaltimoreMaryland21237-
SJMH Cancer CenterAnn ArborMichigan48106-
Nebraska Methodist HospitalOmahaNebraska68114-
Warren HospitalPhillipsburgNew Jersey08865-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
Bronx River Medical Associates, P.C.The BronxNew York10467-
Cancer Care of WNC, PAAshevilleNorth Carolina28801-
Southeastern Medical Oncology CenterGoldsboroNorth Carolina27534-
Southeastern Medical Oncology CenterWilsonNorth Carolina27893-
Samaritan Hematology * OncologyCorvallisOregon97330-
Eastern Regional Medical CenterPhiladelphiaPennsylvania19124-
Associates in Hematology-Oncology PCUplandPennsylvania19013-
Berks Hematology-Oncology Associates, LtdWest ReadingPennsylvania19612-
Charleston Hematology Oncology AssociatesCharlestonSouth Carolina29414-
JTV Cancer Care InstituteRapid CitySouth Dakota57701-
The Jones ClinicGermantownTennessee38138-
Tennessee Cancer SpecialistsKnoxvilleTennessee37920-
Coastal Bend Cancer CenterCorpus ChristiTexas78463-
The Center for Cancer and Blood DisordersFort WorthTexas76104-
The Methodist HospitalHoustonTexas77030-
Cascade Cancer CenterKirklandWashington98304-

Find similar trials in Tucson, AZ

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Arizona Clinical Research Center· Tucson, AZComprehensive Blood and Cancer Center· Bakersfield, CASouthbay Oncology Hematology Partners· Campbell, CABay Area Cancer Research Group, LLC· Concord, CABay Area Cancer Research Group, LLC· Pleasant Hill, CANorth America Research Institute· San Dimas, CA

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