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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00709826
First received: July 1, 2008
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Cancer
Metastatic Pancreatic Cancer
 Drug: gemcitabine
Drug: placebo
Drug: Erlotinib
Drug: apricoxib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tragara Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Randomization then every other cycle ] [ Designated as safety issue: No ]
    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:
  • Overall Survival [ Time Frame: Randomization then every other cycle ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: August 2008
Study Completion Date: May 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709826

  Show 39 Study Locations
Sponsors and Collaborators
Tragara Pharmaceuticals, Inc.
Investigators
Study Director: Tracy Parrott Tragara Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00709826     History of Changes
Other Study ID Numbers: TP2001-203, APRiCOT-P
Study First Received: July 1, 2008
Results First Received: June 18, 2012
Last Updated: October 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013