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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00709826
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : November 7, 2012
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Tragara Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Metastatic Pancreatic Cancer Drug: gemcitabine Drug: placebo Drug: Erlotinib Drug: apricoxib Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : May 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: apricoxib + gemcitabine + erlotinib
400mg apricoxib + 1000mg/m2 gemcitabine + 100mg erlotinib
 Drug: gemcitabine
Gemcitabine: per package insert.
Other Name: Gemcitabine - Gemzar

Drug: Erlotinib
Erlotinib - per package insert.
Other Name: Erlotinib - Tarceva

Drug: apricoxib
apricoxib: 100mg tablets, given orally
Other Name: No other names
Placebo Comparator: placebo + gemcitabine + erlotinib
placebo + 1000mg/m2 gemcitabine + 100mg erlotinib
 Drug: gemcitabine
Gemcitabine: per package insert.
Other Name: Gemcitabine - Gemzar

Drug: placebo
placebo: 100 mg tablets, 400 mg/day
Other Name: No other names

Drug: Erlotinib
Erlotinib - per package insert.
Other Name: Erlotinib - Tarceva


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 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 :
  1. Overall Survival [ Time Frame: Randomization then every other cycle ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709826


Locations
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Sponsors and Collaborators
Tragara Pharmaceuticals, Inc.
Investigators
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Study Director: Tracy Parrott Tragara Pharmaceuticals, Inc.
More Information
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Responsible Party: Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00709826    
Other Study ID Numbers: TP2001-203
APRiCOT-P ( Other Identifier: Tragara Pharmaceuticals )
First Posted: July 3, 2008    Key Record Dates
Results First Posted: November 7, 2012
Last Update Posted: November 7, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors