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

NCT ID: NCT00709826

Last Updated: 2012-11-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer Metastatic Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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apricoxib + gemcitabine + erlotinib

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

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

Gemcitabine: per package insert.

Erlotinib

Intervention Type DRUG

Erlotinib - per package insert.

apricoxib

Intervention Type DRUG

apricoxib: 100mg tablets, given orally

placebo + gemcitabine + erlotinib

placebo + 1000mg/m2 gemcitabine + 100mg erlotinib

Group Type PLACEBO_COMPARATOR

gemcitabine

Intervention Type DRUG

Gemcitabine: per package insert.

placebo

Intervention Type DRUG

placebo: 100 mg tablets, 400 mg/day

Erlotinib

Intervention Type DRUG

Erlotinib - per package insert.

Interventions

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gemcitabine

Gemcitabine: per package insert.

Intervention Type DRUG

placebo

placebo: 100 mg tablets, 400 mg/day

Intervention Type DRUG

Erlotinib

Erlotinib - per package insert.

Intervention Type DRUG

apricoxib

apricoxib: 100mg tablets, given orally

Intervention Type DRUG

Other Intervention Names

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Gemcitabine - Gemzar No other names Erlotinib - Tarceva No other names

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tragara Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracy Parrott

Role: STUDY_DIRECTOR

Tragara Pharmaceuticals, Inc.

Locations

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Arizona Clinical Research Center

Tucson, Arizona, United States

Site Status

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Site Status

Southbay Oncology Hematology Partners

Campbell, California, United States

Site Status

Bay Area Cancer Research Group, LLC

Concord, California, United States

Site Status

Bay Area Cancer Research Group, LLC

Pleasant Hill, California, United States

Site Status

North America Research Institute

San Dimas, California, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Oncology Associates of Bridgeport

Trumball, Connecticut, United States

Site Status

Hematology Oncology Associates

Lake Worth, Florida, United States

Site Status

Hematology Oncology Associates of Treasure Coast

Port Saint Lucie, Florida, United States

Site Status

The Queen's Medical Center Cancer Center

Honolulu, Hawaii, United States

Site Status

Rush-Copley Medical Center

Aurora, Illinois, United States

Site Status

Alexian Brothers Medical Hospital Network

Elk Grove Village, Illinois, United States

Site Status

Investigative Clinical Research of Indiana, LLC

Indianapolis, Indiana, United States

Site Status

Medical Consultants, PC

Muncie, Indiana, United States

Site Status

University of Iowa Hospitals

Iowa City, Iowa, United States

Site Status

Owsley Brown Frazier Cancer Center

Louisville, Kentucky, United States

Site Status

Jayne Gurtler, MD

Metairie, Louisiana, United States

Site Status

Franklin Square Hospital Center/Harry and Jeanette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, United States

Site Status

SJMH Cancer Center

Ann Arbor, Michigan, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Warren Hospital

Phillipsburg, New Jersey, United States

Site Status

San Juan Oncology Associates

Farmington, New Mexico, United States

Site Status

Bronx River Medical Associates, P.C.

The Bronx, New York, United States

Site Status

Cancer Care of WNC, PA

Asheville, North Carolina, United States

Site Status

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

Site Status

Southeastern Medical Oncology Center

Wilson, North Carolina, United States

Site Status

Samaritan Hematology * Oncology

Corvallis, Oregon, United States

Site Status

Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Associates in Hematology-Oncology PC

Upland, Pennsylvania, United States

Site Status

Berks Hematology-Oncology Associates, Ltd

West Reading, Pennsylvania, United States

Site Status

Charleston Hematology Oncology Associates

Charleston, South Carolina, United States

Site Status

JTV Cancer Care Institute

Rapid City, South Dakota, United States

Site Status

The Jones Clinic

Germantown, Tennessee, United States

Site Status

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Site Status

Coastal Bend Cancer Center

Corpus Christi, Texas, United States

Site Status

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

Cascade Cancer Center

Kirkland, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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APRiCOT-P

Identifier Type: OTHER

Identifier Source: secondary_id

TP2001-203

Identifier Type: -

Identifier Source: org_study_id