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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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gemcitabine/abraxane
Gemcitabine and Abraxane
Gemcitabine and Abraxane
Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
Interventions
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Gemcitabine and Abraxane
Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease
* Radiographically measurable or evaluable disease
* Age \>/= 18 years
* ECOG performance status 0-2
* Adequate hepatic, bone marrow and renal function
Exclusion Criteria
* No active severe infection, or known chronic infection with HIV or hepatitis B virus
* No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
* No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception
* Patients with known CNS metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel
* Anticipated patient survival under 2 months
18 Years
ALL
No
Sponsors
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Georgetown University
OTHER
Responsible Party
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Principal Investigators
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Michael Pishvaian, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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LCCC 2013-0138
Identifier Type: -
Identifier Source: org_study_id
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