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Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

Primary Purpose

Metastatic Carcinoma, Recurrent Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemcitabine/Docetaxel
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine/Docetaxel

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

progression free survival
overall survival
Number of Adverse Events

Full Information

First Posted
November 7, 2011
Last Updated
December 28, 2015
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01469598
Brief Title
Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer
Official Title
Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Carcinoma, Recurrent Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine/Docetaxel
Arm Type
Experimental
Arm Description
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
Intervention Type
Drug
Intervention Name(s)
Gemcitabine/Docetaxel
Intervention Description
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
Primary Outcome Measure Information:
Title
Response rate
Time Frame
1years
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
1years
Title
overall survival
Time Frame
1years
Title
Number of Adverse Events
Time Frame
1years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Samsung medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

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