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Phase II Study of Gemcitabine and Celecoxib in Patients With Metastatic Pancreatic Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed Any age NCI MDA-2003-0288
NCI-6167, NCT00068432, 6167

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.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed metastatic pancreatic cancer

Radiographic evidence of disease

No known brain metastases

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

Patient Characteristics:

Age

Any age

Performance status

ECOG 0-2
OR
Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

WBC at least 3,000/mm³
Absolute neutrophil count at least 1,500/mm³
Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 40 patients will be accrued for this study within 8 months.

Outcomes

Primary Outcome(s)

Overall survival at 6 months

Secondary Outcome(s)

Overall response rate
Duration of response
Time to progression
Toxicity
Safety

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Henry Xiong, MD, PhD, Principal investigator(Contact information may not be current)
Ph: 713-792-3859
Brenda Douglas, Study coordinator
Ph: 713-792-3859
Email: mdaccop@mdanderson.org

Registry Information

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

Trial Start Date		2003-12-09

Registered in ClinicalTrials.gov		NCT00068432

Date Submitted to PDQ		2003-07-18

Information Last Verified		2006-06-12

NCI Grant/Contract Number		CA16672

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.