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

Primary Purpose

Pancreatic Cancer, Metastatic Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine
placebo
Erlotinib
apricoxib
Sponsored by
Tragara Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Clinical Research Center
  • Comprehensive Blood and Cancer Center
  • Southbay Oncology Hematology Partners
  • Bay Area Cancer Research Group, LLC
  • Bay Area Cancer Research Group, LLC
  • North America Research Institute
  • Front Range Cancer Specialists
  • Oncology Associates of Bridgeport
  • Hematology Oncology Associates
  • Hematology Oncology Associates of Treasure Coast
  • The Queen's Medical Center Cancer Center
  • Rush-Copley Medical Center
  • Alexian Brothers Medical Hospital Network
  • Investigative Clinical Research of Indiana, LLC
  • Medical Consultants, PC
  • University of Iowa Hospitals
  • Owsley Brown Frazier Cancer Center
  • Jayne Gurtler, MD
  • Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin Square
  • SJMH Cancer Center
  • Nebraska Methodist Hospital
  • Warren Hospital
  • San Juan Oncology Associates
  • Bronx River Medical Associates, P.C.
  • Cancer Care of WNC, PA
  • Southeastern Medical Oncology Center
  • Southeastern Medical Oncology Center
  • Samaritan Hematology * Oncology
  • Eastern Regional Medical Center
  • Associates in Hematology-Oncology PC
  • Berks Hematology-Oncology Associates, Ltd
  • Charleston Hematology Oncology Associates
  • JTV Cancer Care Institute
  • The Jones Clinic
  • Tennessee Cancer Specialists
  • Coastal Bend Cancer Center
  • The Center for Cancer and Blood Disorders
  • The Methodist Hospital
  • Cascade Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

apricoxib + gemcitabine + erlotinib

placebo + gemcitabine + erlotinib

Arm Description

400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib

placebo + 1000mg/m2 gemcitabine + 100mg erlotinib

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival

Full Information

First Posted
July 1, 2008
Last Updated
October 8, 2012
Sponsor
Tragara Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00709826
Brief Title
APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tragara Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Metastatic Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
apricoxib + gemcitabine + erlotinib
Arm Type
Experimental
Arm Description
400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
Arm Title
placebo + gemcitabine + erlotinib
Arm Type
Placebo Comparator
Arm Description
placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
Gemcitabine - Gemzar
Intervention Description
Gemcitabine: per package insert.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
No other names
Intervention Description
placebo: 100 mg tablets, 400 mg/day
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Erlotinib - Tarceva
Intervention Description
Erlotinib - per package insert.
Intervention Type
Drug
Intervention Name(s)
apricoxib
Other Intervention Name(s)
No other names
Intervention Description
apricoxib: 100mg tablets, given orally
Primary Outcome Measure Information:
Title
Progression Free Survival
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.
Time Frame
Randomization then every other cycle
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Randomization then every other cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Parrott
Organizational Affiliation
Tragara Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Southbay Oncology Hematology Partners
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Bay Area Cancer Research Group, LLC
City
Concord
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
Bay Area Cancer Research Group, LLC
City
Pleasant Hill
State/Province
California
ZIP/Postal Code
94523
Country
United States
Facility Name
North America Research Institute
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Front Range Cancer Specialists
City
Ft. Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Oncology Associates of Bridgeport
City
Trumball
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Hematology Oncology Associates
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Hematology Oncology Associates of Treasure Coast
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
The Queen's Medical Center Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Rush-Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Alexian Brothers Medical Hospital Network
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Investigative Clinical Research of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Medical Consultants, PC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
University of Iowa Hospitals
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Owsley Brown Frazier Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40245
Country
United States
Facility Name
Jayne Gurtler, MD
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin Square
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
SJMH Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Warren Hospital
City
Phillipsburg
State/Province
New Jersey
ZIP/Postal Code
08865
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Bronx River Medical Associates, P.C.
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Cancer Care of WNC, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
Samaritan Hematology * Oncology
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Associates in Hematology-Oncology PC
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Berks Hematology-Oncology Associates, Ltd
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612
Country
United States
Facility Name
Charleston Hematology Oncology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
JTV Cancer Care Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
The Jones Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Coastal Bend Cancer Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78463
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cascade Cancer Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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