Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer

NCT00176813 | Completed Phase 2

• 2 other identifiers: UMCC 2001-071C2442
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.

  12 months

Secondary Outcomes (6)

• To obtain data on overall time to disease progression

  12 months

• To determine time to treatment failure

  12 months

• To determine the tolerability of celecoxib with gemcitabine and cisplatin.

  12 months

• To characterize the nature of the toxicity for this combination in this patient group.

  12 months

• To determine objective tumor response

  12 months

Interventions

Gemcitabine DRUG

Cisplatin DRUG

Celecoxib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Eli Lilly and Company: collaborator
• Barbara Ann Karmanos Cancer Institute: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Cisplatin; Celecoxib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles

Study Officials

• Mark Zalupski, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2003
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2006
• Last Updated: May 6, 2008

Record last verified: 2008-04

Locations

US (1)