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Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Cancer

Intervention: Celecoxib (Drug); Gemcitabine Hydrochloride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Henry Q. Xiong, MD, PhD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival at 6 months

Secondary outcome: Overall response rate

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center, Fort Smith, Arkansas 72913, United States

M.D. Anderson Cancer Center - Orlando, Orlando, Florida 32806-2134, United States

CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

CCOP - Columbia River Oncology Program, Portland, Oregon 97225, United States

M.D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

All Saints Cancer Center at All Saints Healthcare, Racine, Wisconsin 53405, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

UT MD Anderson Cancer Center Website

Starting date: December 2003
Last updated: January 9, 2012

Page last updated: August 20, 2015

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