Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer

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 depolymerization.

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.

Inclusion Criteria:

• 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 Criteria:

• 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