APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
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
2 other identifiers
interventional
109
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started Aug 2008
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
November 7, 2012
CompletedNovember 7, 2012
October 1, 2012
1.8 years
July 1, 2008
June 18, 2012
October 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
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.
Randomization then every other cycle
Secondary Outcomes (1)
Overall Survival
Randomization then every other cycle
Study Arms (2)
apricoxib + gemcitabine + erlotinib
EXPERIMENTAL400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
placebo + gemcitabine + erlotinib
PLACEBO COMPARATORplacebo + 1000mg/m2 gemcitabine + 100mg erlotinib
Interventions
Gemcitabine: per package insert.
placebo: 100 mg tablets, 400 mg/day
Erlotinib - per package insert.
apricoxib: 100mg tablets, given orally
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Arizona Clinical Research Center
Tucson, Arizona, 85715, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Southbay Oncology Hematology Partners
Campbell, California, 95008, United States
Bay Area Cancer Research Group, LLC
Concord, California, 94523, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523, United States
North America Research Institute
San Dimas, California, 91773, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80528, United States
Oncology Associates of Bridgeport
Trumball, Connecticut, 06611, United States
Hematology Oncology Associates
Lake Worth, Florida, 33461, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952, United States
The Queen's Medical Center Cancer Center
Honolulu, Hawaii, 96813, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Alexian Brothers Medical Hospital Network
Elk Grove Village, Illinois, 60007, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260, United States
Medical Consultants, PC
Muncie, Indiana, 47303, United States
University of Iowa Hospitals
Iowa City, Iowa, 52242, United States
Owsley Brown Frazier Cancer Center
Louisville, Kentucky, 40245, United States
Jayne Gurtler, MD
Metairie, Louisiana, 70006, United States
Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237, United States
SJMH Cancer Center
Ann Arbor, Michigan, 48106, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Warren Hospital
Phillipsburg, New Jersey, 08865, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Bronx River Medical Associates, P.C.
The Bronx, New York, 10467, United States
Cancer Care of WNC, PA
Asheville, North Carolina, 28801, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
Southeastern Medical Oncology Center
Wilson, North Carolina, 27893, United States
Samaritan Hematology * Oncology
Corvallis, Oregon, 97330, United States
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124, United States
Associates in Hematology-Oncology PC
Upland, Pennsylvania, 19013, United States
Berks Hematology-Oncology Associates, Ltd
West Reading, Pennsylvania, 19612, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29414, United States
JTV Cancer Care Institute
Rapid City, South Dakota, 57701, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37920, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, 78463, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Cascade Cancer Center
Kirkland, Washington, 98304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tracy Parrott
- Organization
- Tragara Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Tracy Parrott
Tragara Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 3, 2008
Study Start
August 1, 2008
Primary Completion
June 1, 2010
Study Completion
May 1, 2011
Last Updated
November 7, 2012
Results First Posted
November 7, 2012
Record last verified: 2012-10