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Keep this study
Lead
Theradex
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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