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

Phase 2

Completed

• Conditions: Pancreatic Cancer; Metastatic Pancreatic Cancer
• Interventions: Drug: gemcitabine; Drug: placebo; Drug: Erlotinib; Drug: apricoxib

• Registration Number: NCT00709826
• Lead Sponsor: Tragara Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Study Start: 2008-08
• Primary Completion: 2010-06
• Study Completion: 2011-05
• Results First Submitted: 2012-06-18
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-08
• Last Update Submitted: 2012-10-08
• Results First Posted: 2012-11-07
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo + gemcitabine + erlotinib	placebo	placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
apricoxib + gemcitabine + erlotinib	Erlotinib	400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
apricoxib + gemcitabine + erlotinib	gemcitabine	400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
placebo + gemcitabine + erlotinib	gemcitabine	placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
placebo + gemcitabine + erlotinib	Erlotinib	placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
apricoxib + gemcitabine + erlotinib	apricoxib	400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Randomization then every other cycle

Trial Locations

Locations (37)

Arizona Clinical Research Center; 🇺🇸 Tucson, Arizona, United States

Comprehensive Blood and Cancer Center; 🇺🇸 Bakersfield, California, United States

Southbay Oncology Hematology Partners; 🇺🇸 Campbell, California, United States

Bay Area Cancer Research Group, LLC; 🇺🇸 Pleasant Hill, California, United States

North America Research Institute; 🇺🇸 San Dimas, California, United States

Front Range Cancer Specialists; 🇺🇸 Ft. Collins, Colorado, United States

Oncology Associates of Bridgeport; 🇺🇸 Trumball, Connecticut, United States

Hematology Oncology Associates; 🇺🇸 Lake Worth, Florida, United States

Hematology Oncology Associates of Treasure Coast; 🇺🇸 Port St. Lucie, Florida, United States

The Queen's Medical Center Cancer Center; 🇺🇸 Honolulu, Hawaii, United States

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