Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068432

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: celecoxib Drug: gemcitabine hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of Gemcitabine and Celecoxib as First-Line Treatment for Patients With Advanced Metastatic Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Celecoxib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Safety [ Designated as safety issue: Yes ]

Study Start Date:

December 2003

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068432

Locations

United States, Arkansas
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72913
United States, Florida
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States, 32806-2134
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Ohio
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Wisconsin
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States, 53405

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Henry Q. Xiong, MD, PhD	M.D. Anderson Cancer Center
Investigator:	Brenda T. Douglas	M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000322827, MDA-2003-0288, NCI-6167
Study First Received:	September 10, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00068432 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Gemcitabine

Endocrine Gland Neoplasms
Celecoxib
Digestive System Neoplasms
Cyclooxygenase Inhibitors
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Analgesics, Non-Narcotic
Pancreatic Diseases
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009