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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709826
• Other study ID #: TP2001-203
• Secondary ID: APRiCOT-P
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2008
• Last updated: October 8, 2012
• Start date: August 2008
• Est. completion date: May 2011

Study information

• Verified date: October 2012
• Source: Tragara Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine
Gemcitabine: per package insert.
• placebo
placebo: 100 mg tablets, 400 mg/day
• Erlotinib
Erlotinib - per package insert.
• apricoxib
apricoxib: 100mg tablets, given orally

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tragara Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall Survival		Randomization then every other cycle	No