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


Phase 2
N/A
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival at 6 months

Outcome Time Frame:

6 Months

Safety Issue:

No

Principal Investigator

Henry Q. Xiong, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2003-0288

NCT ID:

NCT00068432

Start Date:

December 2003

Completion Date:

July 2005

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
M.D. Anderson Cancer Center - OrlandoOrlando, Florida  32806
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFt. Smith, Arkansas  72903
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405