Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer - Full Text View

Sponsor:	University of Michigan Cancer Center
Collaborators:	Eli Lilly and Company Barbara Ann Karmanos Cancer Institute
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00176813

Purpose

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	Intervention	Phase
Pancreatic Cancer	Drug: Gemcitabine Drug: Cisplatin Drug: Celecoxib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Celecoxib

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To obtain data on overall time to disease progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine time to treatment failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine the tolerability of celecoxib with gemcitabine and cisplatin. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
To characterize the nature of the toxicity for this combination in this patient group. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine objective tumor response [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
To determine the influence of therapy on the blood levels of prostaglandins and angiogenesis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	5
Study Start Date:	March 2003
Study Completion Date:	November 2006
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma.
Patients must have clinical/radiologic evidence of metastatic disease (stage IV).
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.
Patients must have performance status of 0-2 on the SWOG scale.
Patients must have an estimated life expectancy of at least 12 weeks.
Patients must have adequate bone marrow function: absolute neutrophil count >1,500/cmm, platelet count >100,000/cmm.
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.
Patients must practice effective birth control while receiving treatment.

Exclusion Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176813

Locations

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan Cancer Center

Eli Lilly and Company

Barbara Ann Karmanos Cancer Institute

Investigators

Principal Investigator:

Mark Zalupski, M.D.

University of Michigan Cancer Center

More Information

No publications provided

Responsible Party:	University of Michigan Comprehensive Cancer Center ( Dr. Mark Zalupski )
Study ID Numbers:	UMCC 2001-071, C2442
Study First Received:	September 9, 2005
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00176813 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms by Site
Cisplatin
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Gemcitabine
Endocrine Gland Neoplasms
Celecoxib
Digestive System Neoplasms
Cyclooxygenase Inhibitors
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Analgesics, Non-Narcotic
Pancreatic Diseases

ClinicalTrials.gov processed this record on February 09, 2010