Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer
NCT ID: NCT01469598
Last Updated: 2015-12-29
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
24 participants
INTERVENTIONAL
2011-08-31
2015-01-31
Brief Summary
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In this study, patients received gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100 mg/m2 on day 8 with G-CSF support every 3 week.
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/Docetaxel
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
Gemcitabine/Docetaxel
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
Interventions
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Gemcitabine/Docetaxel
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* ECOG performance status 0 - 2
* At least one measurable lesion(s) by RECIST 1.1 criteria
* Life expectancy ≥ 3 months
* At least one cytotoxic chemotherapy regimen (adjuvant chemotherapy will be considered as one regimen if administered within 6 months from the date of study entry) (upto three prior regimens will be allowed)
* Prior radiotherapy must be completed 2 weeks before study entry.
* Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
* Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min)
* Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit)
* Written informed consent
Exclusion Criteria
* Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia)
* Serious metabolic disease such as severe non-compensated diabetes mellitus
* History of significant neurologic or psychiatric disorders
* Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
* Pregnant or lactating woman
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Jeeyun Lee
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology
Locations
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Samsung medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2011-03-053
Identifier Type: -
Identifier Source: org_study_id