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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pancreatic Cancer, Metastatic Pancreatic Cancer

In brief

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 facts

Study ID

NCT00709826

Run by

Tragara Pharmaceuticals, Inc.

People needed

109

Starts

2008-08-01

Expected to finish

2011-05-01

Last updated by the study team

2012-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
• Life expectancy greater than or equal to 3 months.
• Patients must have measurable disease by RECIST.
• ECOG PS of 0, 1, or 2.
• Negative serum pregnancy test at the time of first dose for women of childbearing potential.

You may not qualify if…

• Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
• RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
• Evidence of New York Heart Association class III or greater cardiac disease.
• History of myocardial infarction, stroke, ventricular arrhythmia.
• Symptomatic central nervous system metastases.
• Pregnant or nursing women.
• Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
• History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
• Previous anti-EGFR kinase therapy.

Where it is running

• Arizona Clinical Research Center — Tucson, Arizona, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Southbay Oncology Hematology Partners — Campbell, California, United States
• Bay Area Cancer Research Group, LLC — Concord, California, United States
• Bay Area Cancer Research Group, LLC — Pleasant Hill, California, United States
• North America Research Institute — San Dimas, California, United States
• Front Range Cancer Specialists — Fort Collins, Colorado, United States
• Oncology Associates of Bridgeport — Trumball, Connecticut, United States
• Hematology Oncology Associates — Lake Worth, Florida, United States
• Hematology Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
• The Queen's Medical Center Cancer Center — Honolulu, Hawaii, United States
• Rush-Copley Medical Center — Aurora, Illinois, United States
• Alexian Brothers Medical Hospital Network — Elk Grove Village, Illinois, United States
• Investigative Clinical Research of Indiana, LLC — Indianapolis, Indiana, United States
• Medical Consultants, PC — Muncie, Indiana, United States
• University of Iowa Hospitals — Iowa City, Iowa, United States
• Owsley Brown Frazier Cancer Center — Louisville, Kentucky, United States
• Jayne Gurtler, MD — Metairie, Louisiana, United States
• Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin Square — Baltimore, Maryland, United States
• SJMH Cancer Center — Ann Arbor, Michigan, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Warren Hospital — Phillipsburg, New Jersey, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• Bronx River Medical Associates, P.C. — The Bronx, New York, United States
• Cancer Care of WNC, PA — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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