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Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer

Inclusion Criteria

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Mark Zalupski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Food and Drug Administration

Study ID:

UMCC 2001-071



Start Date:

March 2003

Completion Date:

November 2006

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms



University of MichiganAnn Arbor, Michigan  48109-0624