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

October 8, 2012 updated by: Tragara Pharmaceuticals, Inc.

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 in patients with advanced pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Campbell, California, United States, 95008
        • Southbay Oncology Hematology Partners
      • Concord, California, United States, 94523
        • Bay Area Cancer Research Group, LLC
      • Pleasant Hill, California, United States, 94523
        • Bay Area Cancer Research Group, LLC
      • San Dimas, California, United States, 91773
        • North America Research Institute
    • Colorado
      • Ft. Collins, Colorado, United States, 80528
        • Front Range Cancer Specialists
    • Connecticut
      • Trumball, Connecticut, United States, 06611
        • Oncology Associates of Bridgeport
    • Florida
      • Lake Worth, Florida, United States, 33461
        • Hematology Oncology Associates
      • Port St. Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of Treasure Coast
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center Cancer Center
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush-Copley Medical Center
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Medical Hospital Network
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Investigative Clinical Research of Indiana, LLC
      • Muncie, Indiana, United States, 47303
        • Medical Consultants, Pc
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals
    • Kentucky
      • Louisville, Kentucky, United States, 40245
        • Owsley Brown Frazier Cancer Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Jayne Gurtler, MD
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin Square
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • SJMH Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • New Jersey
      • Phillipsburg, New Jersey, United States, 08865
        • Warren Hospital
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • Bronx, New York, United States, 10467
        • Bronx River Medical Associates, P.C.
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Cancer Care of WNC, PA
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center
      • Wilson, North Carolina, United States, 27893
        • Southeastern Medical Oncology Center
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Samaritan Hematology * Oncology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19124
        • Eastern Regional Medical Center
      • Upland, Pennsylvania, United States, 19013
        • Associates in Hematology-Oncology PC
      • West Reading, Pennsylvania, United States, 19612
        • Berks Hematology-Oncology Associates, Ltd
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • JTV Cancer Care Institute
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic
      • Knoxville, Tennessee, United States, 37920
        • Tennessee Cancer Specialists
    • Texas
      • Corpus Christi, Texas, United States, 78463
        • Coastal Bend Cancer Center
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Washington
      • Kirkland, Washington, United States, 98304
        • Cascade Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: apricoxib + gemcitabine + erlotinib
400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
Drug: gemcitabine
Gemcitabine: per package insert.
Other Names:
  • Gemcitabine - Gemzar
Drug: Erlotinib
Erlotinib - per package insert.
Other Names:
  • Erlotinib - Tarceva
Drug: apricoxib
apricoxib: 100mg tablets, given orally
Other Names:
  • No other names
Placebo Comparator: placebo + gemcitabine + erlotinib
placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
Drug: gemcitabine
Gemcitabine: per package insert.
Other Names:
  • Gemcitabine - Gemzar
Drug: Erlotinib
Erlotinib - per package insert.
Other Names:
  • Erlotinib - Tarceva
Drug: placebo
placebo: 100 mg tablets, 400 mg/day
Other Names:
  • No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 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.
Randomization then every other cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Randomization then every other cycle
Randomization then every other cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tragara Pharmaceuticals, Inc.

Investigators

  • Study Director: Tracy Parrott, Tragara Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

October 8, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP2001-203
  • APRiCOT-P (Other Identifier: Tragara Pharmaceuticals)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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