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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01469598

Enrollment

Registered

2011-11-10

Start date

2011-08-31

Completion date

2015-01-31

Last updated

2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Carcinoma, Recurrent Esophageal Squamous Cell Carcinoma

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.

Interventions

DRUGGemcitabine/Docetaxel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate	1years

Secondary

Measure	Time frame
progression free survival	1years
overall survival	1years
Number of Adverse Events	1years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026