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APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer, Metastatic Pancreatic Cancer

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Trial Information

APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer


This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with
placebo and gemcitabine/erlotinib as measured by progression-free survival to test the
hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated
COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib
only.


Inclusion Criteria:



1. Histologically or cytologically confirmed adenocarcinoma of the pancreas that is
locally advanced or metastatic.

2. Life expectancy greater than or equal to 3 months.

3. Patients must have measurable disease by RECIST.

4. ECOG PS of 0, 1, or 2.

5. Negative serum pregnancy test at the time of first dose for women of childbearing
potential.

Exclusion Criteria:

1. Previous chemotherapy as primary treatment for locally advanced or metastatic
pancreatic cancer(stage 3 T3 and T4, and all stage 4).

2. RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational
agents within 4 weeks of initiating study treatment.

3. Evidence of New York Heart Association class III or greater cardiac disease.

4. History of myocardial infarction, stroke, ventricular arrhythmia.

5. Symptomatic central nervous system metastases.

6. Pregnant or nursing women.

7. Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides,
aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).

8. History of upper gastrointestinal bleeding, ulceration or perforation. History of
lower GI bleeding, ulceration, or perforation within 12 months.

9. Previous anti-EGFR kinase therapy.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

Outcome Time Frame:

Randomization then every other cycle

Safety Issue:

No

Principal Investigator

Tracy Parrott

Investigator Role:

Study Director

Investigator Affiliation:

Tragara Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

TP2001-203

NCT ID:

NCT00709826

Start Date:

August 2008

Completion Date:

May 2011

Related Keywords:

  • Pancreatic Cancer
  • Metastatic Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Warren HospitalPhillipsburg, New Jersey  08865
Hematology Oncology AssociatesAtlantis, Florida  33462
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Arizona Clinical Research CenterTucson, Arizona  85712
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Tennessee Cancer SpecialistsKnoxville, Tennessee  37920
Nebraska Methodist HospitalOmaha, Nebraska  68114
Cascade Cancer CenterKirkland, Washington  98034-3013
Medical Consultants, PCMuncie, Indiana  47304
The Methodist HospitalHouston, Texas  77030
The Center for Cancer and Blood DisordersFort Worth, Texas  76104
Bay Area Cancer Research Group, LLCConcord, California  94520
San Juan Oncology AssociatesFarmington, New Mexico  87401
Hematology Oncology Associates of Treasure CoastPort St. Lucie, Florida  34952
The Jones ClinicGermantown, Tennessee  38138
Oncology Associates of BridgeportTrumball, Connecticut  06611
Southbay Oncology Hematology PartnersCampbell, California  95008
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana  46254
Charleston Hematology Oncology AssociatesCharleston, South Carolina  29403
North America Research InstituteSan Dimas, California  
SJMH Cancer CenterAnn Arbor, Michigan  
Eastern Regional Medical CenterPhiladelphia, Pennsylvania  
Associates in Hematology-Oncology PCUpland, Pennsylvania  
University of Iowa HospitalsIowa City, Iowa  52242
Owsley Brown Frazier Cancer CenterLouisville, Kentucky  40245
Bronx River Medical Associates, P.C.Bronx, New York  10467
The Queen's Medical Center Cancer CenterHonolulu, Hawaii  96813
Rush-Copley Medical CenterAurora, Illinois  60504
Alexian Brothers Medical Hospital NetworkElk Grove Village, Illinois  60007
Jayne Gurtler, MDMetairie, Louisiana  70006
Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin SquareBaltimore, Maryland  21237
Cancer Care of WNC, PAAsheville, North Carolina  28801
Samaritan Hematology * OncologyCorvallis, Oregon  97330
Berks Hematology-Oncology Associates, LtdWest Reading, Pennsylvania  19612
JTV Cancer Care InstituteRapid City, South Dakota  57701