Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

NCT01469598 | Completed Phase 2

• 1 other identifier: 2011-03-053
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Carcinoma; Recurrent Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Response rate

  1years

Secondary Outcomes (3)

• progression free survival

  1years

• overall survival

  1years

• Number of Adverse Events

  1years

Study Arms (1)

Gemcitabine/Docetaxel

EXPERIMENTAL

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

Drug: Gemcitabine/Docetaxel

Interventions

Gemcitabine/Docetaxel DRUG

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

Gemcitabine/Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma; Esophageal Squamous Cell Carcinoma

Interventions

Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 10, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: January 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

KR (1)