Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

NCT00068432 | Completed Phase 2

• 5 other identifiers: 2003-0288P30CA016672MDA-2003-0288NCI-6167CDR0000322827
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival at 6 months

  6 Months

Secondary Outcomes (1)

• Overall response rate

  6 months

Study Arms (1)

Gemcitabine + Celecoxib

EXPERIMENTAL

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

Drug: Celecoxib; Drug: Gemcitabine Hydrochloride

Interventions

Celecoxib DRUG

Oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks.

Also known as: Celebrex

Gemcitabine + Celecoxib

Gemcitabine Hydrochloride DRUG

Receive gemcitabine by vein (IV) over 65 minutes on days 1, 8 and 15. Courses repeat every 4 weeks.

Also known as: Gemcitabine, Gemzar

Gemcitabine + Celecoxib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, 72913, United States

Location

M.D. Anderson Cancer Center - Orlando

Orlando, Florida, 32806-2134, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

All Saints Cancer Center at All Saints Healthcare

Racine, Wisconsin, 53405, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Celecoxib; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Study Officials

• Henry Q. Xiong, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: December 1, 2003
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (11)