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Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

This study is currently recruiting participants.
Verified November 2011 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01469598
First received: November 7, 2011
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 32
Study Start Date: August 2011
Estimated Primary Completion Date: March 2012 (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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469598

Contacts
Contact: mi yeon kwon, RN +82-2-3410-1248 miyeon.kwon@samsung.com

Locations
Korea, Republic of
Samsung medical Center Recruiting
Seoul, Korea, Republic of
Contact: mi yeon kwon, RN     +82-2-3410-1248     miyeon.kwon@samsung.com    
Principal Investigator: Jee yun Lee, MD            
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jeeyun Lee, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01469598     History of Changes
Other Study ID Numbers: 2011-03-053
Study First Received: November 7, 2011
Last Updated: November 9, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Esophageal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 19, 2013