Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

This study has been completed.
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center Identifier:
First received: November 7, 2011
Last updated: December 28, 2015
Last verified: December 2015

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.

Condition Intervention Phase
Metastatic Carcinoma
Recurrent Esophageal Squamous Cell Carcinoma
Drug: Gemcitabine/Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 1years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 1years ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 1years ] [ Designated as safety issue: No ]
  • Number of Adverse Events [ Time Frame: 1years ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: August 2011
Study Completion Date: January 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine/Docetaxel
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
Drug: Gemcitabine/Docetaxel
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01469598

Korea, Republic of
Samsung medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Jeeyun Lee, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center Identifier: NCT01469598     History of Changes
Other Study ID Numbers: 2011-03-053 
Study First Received: November 7, 2011
Last Updated: December 28, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents processed this record on May 02, 2016