Clinical trial · Interventional
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
NCT01469598CI-TRIAL-00020365completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Carcinoma | Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine/Docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine/Docetaxel
- description
- Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
- interventionNames
- Drug: Gemcitabine/Docetaxel
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 1years
Secondary outcomes (3)
- measure
- progression free survival
- timeFrame
- 1years
- measure
- overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.