Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer



Status:Completed
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/2/2018
Start Date:December 2003
End Date:July 2005

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A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, use different ways to stop tumor
cells from dividing so they stop growing or die. Celecoxib may stop the growth of pancreatic
cancer by stopping blood flow to the tumor and blocking the enzymes necessary for tumor cell
growth. Combining gemcitabine with celecoxib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with celecoxib
works in treating patients with 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.

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
We found this trial at
11
sites
Atlanta, Georgia 30342
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1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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Orlando, FL
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Dayton, Ohio 45420
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Dayton, OH
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Fort Smith, AR
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Houston, TX
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Kansas City, Missouri 64131
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Kansas City, MO
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Portland, OR
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Racine, WI
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1730 E Republic Rd
Springfield, Missouri 65804
(417) 269-4520
CCOP - Cancer Research for the Ozarks Cancer Research for the Ozarks (CRO), also known...
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Springfield, MO
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509 W. University Avenue
Urbana, Illinois 61801
(217) 383-3516
CCOP - Carle Cancer Center The Carle Cancer Center Community Clinical Oncology Program (CCOP) in...
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Urbana, IL
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Wichita, Kansas 67214
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Wichita, KS
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