Status:
COMPLETED
Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Eli Lilly and Company
Barbara Ann Karmanos Cancer Institute
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 red...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00176813
Start Date
March 1 2003
End Date
November 1 2006
Last Update
May 6 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48109