Status:
COMPLETED
Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Metastatic Carcinoma
Recurrent Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Gemcitabine is a novel analog of the nucleoside deoxycytidine that acts via inhibition of DNA synthesis.Docetaxel is a semisynthetic taxane and promotes microtubule assembly and inhibits microtubule d...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma
- 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
- Evidence of serious gastrointestinal bleeding
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01469598
Start Date
August 1 2011
End Date
January 1 2015
Last Update
December 29 2015
Active Locations (1)
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1
Samsung medical Center
Seoul, South Korea