Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT00111904
Last Updated: 2011-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2005-05-31
Brief Summary
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PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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paclitaxel-loaded polymeric micelle
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Theradex
INDUSTRY
Principal Investigators
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John S. MacDonald, MD
Role: STUDY_CHAIR
Beth Israel Comprehensive Cancer Center - West Side Campus
Locations
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Florida Cancer Specialists - Bonita Springs
Bonita Springs, Florida, United States
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, United States
Louisiana Oncology Associates - Lafayette
Lafayette, Louisiana, United States
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, United States
Southwest Regional Cancer Center - Central
Austin, Texas, United States
Countries
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References
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Saif MW, Podoltsev NA, Rubin MS, Figueroa JA, Lee MY, Kwon J, Rowen E, Yu J, Kerr RO. Phase II clinical trial of paclitaxel loaded polymeric micelle in patients with advanced pancreatic cancer. Cancer Invest. 2010 Feb;28(2):186-94. doi: 10.3109/07357900903179591.
Other Identifiers
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TARGET-S04-10485
Identifier Type: -
Identifier Source: secondary_id
WIRB-20050099
Identifier Type: -
Identifier Source: secondary_id
CDR0000433513
Identifier Type: -
Identifier Source: org_study_id