Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068432
• Other study ID #: 2003-0288
• Secondary ID: P30CA016672MDA-2
• Status: Completed
• Phase: Phase 2
• Start date: December 2003
• Est. completion date: July 2005

Study information

• Verified date: October 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Celecoxib
Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.
• Gemcitabine Hydrochloride
Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.

Locations

Country	Name	City	State
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	CCOP - Dayton	Dayton	Ohio
United States	Hembree Mercy Cancer Center at St. Edward Mercy Medical Center	Fort Smith	Arkansas
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	CCOP - Kansas City	Kansas City	Missouri
United States	M.D. Anderson Cancer Center - Orlando	Orlando	Florida
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	All Saints Cancer Center at All Saints Healthcare	Racine	Wisconsin
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival at 6 months		6 Months
Secondary	Overall response rate		6 months

External Links

•   UT MD Anderson Cancer Center Website