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

Study Overview
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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.

Official Title
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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

Conditions
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Pancreatic Cancer, Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: placebo
* Drug: Erlotinib
* Drug: apricoxib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apricoxib + gemcitabine + erlotinib<br>400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib | Drug: gemcitabine<br>* Gemcitabine: per package insert.<br>* Other names: Gemcitabine - Gemzar;Drug: Erlotinib<br>* Erlotinib - per package insert.<br>* Other names: Erlotinib - Tarceva;Drug: apricoxib<br>* apricoxib: 100mg tablets, given orally<br>* Other names: No other names;|
| Placebo Comparator: placebo + gemcitabine + erlotinib<br>placebo + 1000mg/m2 gemcitabine + 100mg erlotinib | Drug: gemcitabine<br>* Gemcitabine: per package insert.<br>* Other names: Gemcitabine - Gemzar;Drug: placebo<br>* placebo: 100 mg tablets, 400 mg/day<br>* Other names: No other names;Drug: Erlotinib<br>* Erlotinib - per package insert.<br>* Other names: Erlotinib - Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Randomization then every other cycle |