Expired Study
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Miami, Florida 33136


RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, 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 albumin-stabilized nanoparticle formulation works in treating patients with locally advanced or metastatic pancreatic cancer that did not respond to first-line therapy with gemcitabine.

Study summary:

OBJECTIVES: Primary - To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized nanoparticle formulation in patients with locally advanced (unresectable) or metastatic pancreatic cancer that failed first-line therapy with a gemcitabine hydrochloride-containing regimen. Secondary - To determine the safety and characterize the toxicity profile of this drug. - To determine the complete, partial, and overall response rates and duration of response in patients with measurable disease. - To determine CA 19-9 response. - To determine progression-free survival. OUTLINE: This is a multicenter study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year and then annually thereafter.


DISEASE CHARACTERISTICS: - Histologically confirmed pancreatic cancer - Locally advanced (unresectable) or metastatic disease - Must have failed first-line treatment with a gemcitabine hydrochloride-containing regimen - Measurable or nonmeasurable disease by RECIST criteria PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy > 3 months - Neutrophils ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin ≥ 9.0 g/dL - Serum creatinine ≤ 1.5 mg/dL - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - ALT and AST ≤ 2.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No peripheral neuropathy ≥ grade 2 - No clinical AIDS or known positive HIV serology - No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years - No unstable angina - No New York Heart Association class II-IV congestive heart failure - No myocardial infarction within the past 3 months - No stroke within the past 3 months - No significant traumatic injury within the past 28 days - No serious medical or psychiatric illness that would render chemotherapy unsafe PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior therapy - More than 3 weeks since prior chemotherapy - More than 2 weeks since prior radiotherapy - More than 4 weeks since prior major surgery or open biopsy - More than 4 weeks since prior experimental drug - At least 3 weeks since other prior therapy - No concurrent major surgery - No concurrent radiotherapy - No other concurrent chemotherapy, immunotherapy, or antitumor hormonal therapy



Primary Contact:

Study Chair
Caio Max S. Rocha Lima, MD
University of Miami Sylvester Comprehensive Cancer Center

Backup Contact:


Location Contact:

Miami, Florida 33136
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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