Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

Phase 2

Completed

• Conditions: Metastatic Carcinoma; Recurrent Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Gemcitabine/Docetaxel

• Registration Number: NCT01469598
• Lead Sponsor: Samsung Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-10
• Primary Completion: 2014-02
• Study Completion: 2015-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine/Docetaxel	Gemcitabine/Docetaxel	Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days

Primary Outcome Measures

Name	Time	Method
Response rate	1years

Secondary Outcome Measures

Name	Time	Method
overall survival	1years
Number of Adverse Events	1years
progression free survival	1years

Trial Locations

Locations (1)

Samsung medical Center; 🇰🇷 Seoul, Korea, Republic of