Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01469598
First received: November 7, 2011
Last updated: May 13, 2014
Last verified: May 2014

November 7, 2011
May 13, 2014
August 2011
February 2014   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 1years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01469598 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer
Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Carcinoma
  • Recurrent Esophageal Squamous Cell Carcinoma
Drug: Gemcitabine/Docetaxel
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
Experimental: Gemcitabine/Docetaxel
Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
Intervention: Drug: Gemcitabine/Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
December 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01469598
2011-03-053
No
Jeeyun Lee, Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP