Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00176813
• Other study ID #: UMCC 2001-071
• Secondary ID: C2442
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: April 29, 2008
• Start date: March 2003
• Est. completion date: November 2006

Study information

• Verified date: April 2008
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2006
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine

• Cisplatin

• Celecoxib

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	Barbara Ann Karmanos Cancer Institute, Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.		12 months	No
Secondary	To obtain data on overall time to disease progression		12 months	No
Secondary	To determine time to treatment failure		12 months	No
Secondary	To determine the tolerability of celecoxib with gemcitabine and cisplatin.		12 months	Yes
Secondary	To characterize the nature of the toxicity for this combination in this patient group.		12 months	No
Secondary	To determine objective tumor response		12 months	Yes
Secondary	To determine the influence of therapy on the blood levels of prostaglandins and angiogenesis		12 months	Yes