A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer
N/A
N/A
Both
Pancreatic Cancer
Trial Information
A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer
OBJECTIVES:
- Determine the overall survival at 6 months in patients with metastatic pancreatic
cancer treated with gemcitabine and celecoxib.
- Determine the objective tumor response, progression-free survival, and median survival
of patients treated with this regimen.
- Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive gemcitabine IV over 65 minutes on days 1, 8, and 15 and oral celecoxib
twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression
or unacceptable toxicity.
Patients are followed monthly for 6 months from study entry and then every 3 months
thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 8 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic pancreatic cancer
- Radiographic evidence of disease
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
Renal
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Gastrointestinal
- No history of peptic ulcer disease
- No gastrointestinal bleeding within the past 3 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reactions to compounds of similar chemical or biological
composition to study drugs or to sulfonamides
- No prior allergic reaction, asthma, or urticaria after taking aspirin or NSAIDs
- No ongoing or active infection
- No other uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- No other malignancy within the past 5 years except basal cell skin cancer or
carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for metastatic pancreatic cancer
- More than 6 months since prior neoadjuvant or adjuvant chemoradiotherapy (including
gemcitabine) for pancreatic cancer
Endocrine therapy
- Not specified
Radiotherapy
- See Chemotherapy
- More than 6 months since prior radiotherapy
Surgery
- Not specified
Other
- More than 30 days since prior investigational agents
- No other concurrent investigational or commercial agents or therapies for the
malignancy
- No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
- No other concurrent cyclo-oxygenase-2 (COX-2) inhibitors (e.g., rofecoxib)
- Concurrent acetaminophen-containing medications or low-dose aspirin (up to 325
mg/day) for cardiac prophylaxis allowed
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival at 6 months
Outcome Time Frame:
6 Months
Safety Issue:
No
Principal Investigator
Henry Q. Xiong, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2003-0288
NCT ID:
NCT00068432
Start Date:
December 2003
Completion Date:
July 2005
Related Keywords:
- Pancreatic Cancer
- recurrent pancreatic cancer
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| M.D. Anderson Cancer Center - Orlando | Orlando, Florida 32806 |
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Ft. Smith, Arkansas 72903 |
| All Saints Cancer Center at All Saints Healthcare | Racine, Wisconsin 53405 |
