Pancreatic Cancer
Conditions
Keywords
stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | — |
| Time to treatment failure | — |
| Best overall response rate | — |
| Overall survival | — |
| Clinical benefit | — |
| Safety | — |
Countries
United States