RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.

Condition	Treatment or Intervention	Phase
stage III pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer recurrent pancreatic cancer	Drug: paclitaxel loaded polymeric micelle  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol^® -PM).
• Determine the best overall response rate and duration of response in patients treated with this drug.
• Determine the overall survival of patients treated with this drug.
• Determine the clinical benefit and safety of this drug in these patients.

OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^® -PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed epithelial carcinoma of the pancreas
• Unresectable* locally advanced or metastatic disease NOTE: *Documented by high-quality contrast-enhanced CT scan
• No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ
• No unstable or serious medical condition
• No psychiatric disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for pancreatic cancer
• Prior fluorouracil as a radiosensitizer allowed

Endocrine therapy

• Not specified

Radiotherapy

• More than 6 weeks since prior radiotherapy for pancreatic cancer
• Disease must have progressed after completion of radiotherapy

Surgery

• More than 14 days since prior major surgery and recovered

Other

• More than 30 days since prior investigational agents

Please refer to this study by ClinicalTrials.gov identifier  NCT00111904

Florida
      Florida Cancer Specialists - Bonita Springs, Bonita Springs,  Florida,  34135,  United States; Recruiting
Illinois
      Midwest Cancer Research Group, Incorporated, Skokie,  Illinois,  60077,  United States; Recruiting
Louisiana
      Louisiana Oncology Associates - Lafayette, Lafayette,  Louisiana,  70506,  United States; Recruiting
New York
      St. Vincent''''s Comprehensive Cancer Center - Manhattan, New York,  New York,  10011,  United States; Recruiting
Texas
      Southwest Regional Cancer Center - Central, Austin,  Texas,  78705,  United States; Recruiting

Study chairs or principal investigators

John S. Macdonald, MD,  Study Chair,  St. Vincent''''s Comprehensive Cancer Center - Manhattan   

Study ID Numbers:  CDR0000433513; THERADEX-S04-10485; WIRB-20050099
Record last reviewed:  May 2005
Last Updated:  May 26, 2005
Record first received:  May 26, 2005
ClinicalTrials.gov Identifier:  NCT00111904
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-31