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

Phase 2

Completed

Conditions: Pancreatic Cancer
Metastatic Pancreatic Cancer

Interventions: Drug: gemcitabine
Drug: placebo
Drug: Erlotinib
Drug: apricoxib

Registration Number: NCT00709826

Lead Sponsor: Tragara Pharmaceuticals, Inc.

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 109

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo + gemcitabine + erlotinib	placebo	placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
apricoxib + gemcitabine + erlotinib	Erlotinib	400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
apricoxib + gemcitabine + erlotinib	gemcitabine	400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
placebo + gemcitabine + erlotinib	gemcitabine	placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
placebo + gemcitabine + erlotinib	Erlotinib	placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
apricoxib + gemcitabine + erlotinib	apricoxib	400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Randomization then every other cycle	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Randomization then every other cycle

Trial Locations

Locations (37): The Queen's Medical Center Cancer Center
🇺🇸
Honolulu, Hawaii, United States
Front Range Cancer Specialists
🇺🇸
Ft. Collins, Colorado, United States
Bronx River Medical Associates, P.C.
🇺🇸
Bronx, New York, United States
Southbay Oncology Hematology Partners
🇺🇸
Campbell, California, United States
Bay Area Cancer Research Group, LLC
🇺🇸
Pleasant Hill, California, United States
North America Research Institute
🇺🇸
San Dimas, California, United States
Hematology Oncology Associates of Treasure Coast
🇺🇸
Port St. Lucie, Florida, United States
Oncology Associates of Bridgeport
🇺🇸
Trumball, Connecticut, United States
Medical Consultants, PC
🇺🇸
Muncie, Indiana, United States
University of Iowa Hospitals
🇺🇸
Iowa City, Iowa, United States
Alexian Brothers Medical Hospital Network
🇺🇸
Elk Grove Village, Illinois, United States
San Juan Oncology Associates
🇺🇸
Farmington, New Mexico, United States
Southeastern Medical Oncology Center
🇺🇸
Wilson, North Carolina, United States
Cancer Care of WNC, PA
🇺🇸
Asheville, North Carolina, United States
Associates in Hematology-Oncology PC
🇺🇸
Upland, Pennsylvania, United States
Berks Hematology-Oncology Associates, Ltd
🇺🇸
West Reading, Pennsylvania, United States
The Jones Clinic
🇺🇸
Germantown, Tennessee, United States
The Center for Cancer and Blood Disorders
🇺🇸
Fort Worth, Texas, United States
Cascade Cancer Center
🇺🇸
Kirkland, Washington, United States
Eastern Regional Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Comprehensive Blood and Cancer Center
🇺🇸
Bakersfield, California, United States
Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin Square
🇺🇸
Baltimore, Maryland, United States
Rush-Copley Medical Center
🇺🇸
Aurora, Illinois, United States
Investigative Clinical Research of Indiana, LLC
🇺🇸
Indianapolis, Indiana, United States
Owsley Brown Frazier Cancer Center
🇺🇸
Louisville, Kentucky, United States
SJMH Cancer Center
🇺🇸
Ann Arbor, Michigan, United States
Coastal Bend Cancer Center
🇺🇸
Corpus Christi, Texas, United States
The Methodist Hospital
🇺🇸
Houston, Texas, United States
JTV Cancer Care Institute
🇺🇸
Rapid City, South Dakota, United States
Tennessee Cancer Specialists
🇺🇸
Knoxville, Tennessee, United States
Nebraska Methodist Hospital
🇺🇸
Omaha, Nebraska, United States
Hematology Oncology Associates
🇺🇸
Lake Worth, Florida, United States
Charleston Hematology Oncology Associates
🇺🇸
Charleston, South Carolina, United States
Arizona Clinical Research Center
🇺🇸
Tucson, Arizona, United States
Jayne Gurtler, MD
🇺🇸
Metairie, Louisiana, United States
Samaritan Hematology * Oncology
🇺🇸
Corvallis, Oregon, United States
Warren Hospital
🇺🇸
Phillipsburg, New Jersey, United States