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Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic 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. Identifier: NCT00176813
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 6, 2008
Eli Lilly and Company
Barbara Ann Karmanos Cancer Institute
Information provided by:
University of Michigan Rogel Cancer Center

Brief Summary:

This study will examine an investigational (experimental) treatment using gemcitabine, cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may be effective in reducing the size of cancerous tumors and/or preventing further tumor growth.

This is a phase II clinical trial studying the reactions of the patient's body and their tumor to the combination of gemcitabine, cisplatin, and celecoxib. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. This study will also look at what kind of side effects this experimental treatment causes and see how often these side effects occur. Blood levels of celecoxib will be measured to find out how this treatment affects factors (proteins) involved in new blood vessel formation and tumor growth (angiogenesis).

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Drug: Cisplatin Drug: Celecoxib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer
Study Start Date : March 2003
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2006

Primary Outcome Measures :
  1. To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To obtain data on overall time to disease progression [ Time Frame: 12 months ]
  2. To determine time to treatment failure [ Time Frame: 12 months ]
  3. To determine the tolerability of celecoxib with gemcitabine and cisplatin. [ Time Frame: 12 months ]
  4. To characterize the nature of the toxicity for this combination in this patient group. [ Time Frame: 12 months ]
  5. To determine objective tumor response [ Time Frame: 12 months ]
  6. To determine the influence of therapy on the blood levels of prostaglandins and angiogenesis [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma.
  2. Patients must have clinical/radiologic evidence of metastatic disease (stage IV).
  3. Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed, provided that the last day of therapy was at least 6 months prior to starting treatment.
  4. Patients must have performance status of 0-2 on the SWOG scale.
  5. Patients must have an estimated life expectancy of at least 12 weeks.
  6. Patients must have adequate bone marrow function: absolute neutrophil count >1,500/cmm, platelet count >100,000/cmm.
  7. Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.
  8. Patients must practice effective birth control while receiving treatment.

Exclusion Criteria

  1. Patients with endocrine tumors or lymphoma of the pancreas.
  2. Patients with locally advanced pancreatic cancer.
  3. Patients with a proven history (radiographic and/or endoscopic) of peptic ulcer or esophageal erosions within one year of enrollment onto the study.
  4. Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
  5. History of active central nervous system (CNS) metastases.
  6. Inadequate liver function (bilirubin >3.0 mg/dL); transaminases (AST/ALT) >3 times upper limit of institutional normal.
  7. Inadequate renal function (creatinine >1.5 mg/dL).
  8. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
  9. History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
  10. Unresolved bacterial infection requiring treatment with antibiotics.
  11. Pregnant or lactating women may not participate in the study.
  12. Patients who have allergy to any of the study drugs or sulfa drugs.
  13. Patients infected with HIV-1 virus because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.

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 identifier (NCT number): NCT00176813

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Eli Lilly and Company
Barbara Ann Karmanos Cancer Institute
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Principal Investigator: Mark Zalupski, M.D. University of Michigan Rogel Cancer Center

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Responsible Party: Dr. Mark Zalupski, University of Michigan Comprehensive Cancer Center Identifier: NCT00176813     History of Changes
Other Study ID Numbers: UMCC 2001-071
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors