Clinical trial NCT00709826: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Metastatic Pancreatic Cancer
Lead sponsor: Tragara Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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