Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

Metastatic Carcinoma Clinical Trial

Official title:

Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469598
• Other study ID #: 2011-03-053
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2011
• Last updated: December 28, 2015
• Start date: August 2011
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Metastatic Carcinoma
• Recurrent Esophageal Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		1years	No
Secondary	progression free survival		1years	No
Secondary	overall survival		1years	No
Secondary	Number of Adverse Events		1years	Yes