Clinical trial · Interventional
Docetaxel and Epirubicin in Advanced Gastric Cancer
A Phase II Study of Docetaxel and Epirubicin Combination in Patients With Advanced Gastric Cancer.
- 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)
1.Study rationale:There is no standard regimen for the advanced and/or metastatic gastric cancer patients who relapsed after adjuvant chemotherapy or failed to first systemic chemotherapy. 2.Primary Objectives:To evaluate overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria and To investigate time to response 3.Design:single-center, Open label, Phase II study. docetaxel 75mg/m2 administered on day 1 as intravenously combined with intravenous Epirubicin 60mg/m2 given day 2 every 3 weeks. 4.Primary endpoints: 1. Efficacy:overall response rate according to the Response Evaluation Criteria in Solid Tumors criteria, time to response, duration of response, and time to treatment failure. 2. Safety-Adverse events and laboratory tests, graded according to the NCI Common Toxicity Criteria for Adverse Effects (version 3.0).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel and epirubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- docetaxel and epirubicin
- description
- salvage docetaxel and epirubicin
- interventionNames
- Drug: Docetaxel and epirubicin
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female outpatients ≥ 18 years, * Eastern Cooperative Oncology Group performance status below 1, with histologically confirmed as gastric adenocarcinoma with inoperable and/or metastatic disease. * Patients must have at least one target lesion with a minimum lesion size as per the Response Evaluation Criteria in Solid Tumors criteria (at least 1 unidimensional measurable lesion ≥ 20 mm in diameter by conventional CT or MRI scan, or ≥ 10 mm in diameter by spiral CT scan). * Creatinine clearance ≥ 60ml/min (estimated creatinine clearance must be calculated at baseline for all patients.) * Adequate major organ function : - Hematopoietic function: white blood cell \>4,000/mm3 or absolute neutrophil count \> 2,000/mm3, Platelet count ≥ 100,000/mm3,- Hepatic function: Bilirubin \< 1.5 X upper normal limit, aspartate aminotransferase/alanine aminotransferase levels \<2.5 X upper normal limit, alkaline phosphatase \< 5 x upper normal limit (except in case of bone metastasis without any liver disease) - Renal function: Creatinine \<1 x upper normal limit or creatinine clearance ≥ 60ml/min. Exclusion Criteria: * Patients must not have previously received systemic treatment (cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic disease. * Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment. * The following laboratory values: - neutrophils ≤1.5 X 109 /L, platelet count\<100 X 109 /L- serum bilirubin ≥ 1.5 X upper normal limit, aspartate aminotransferase , alanine aminotransferase \> 2.5 X upper normal limit or \> 5 X upper normal limit in the case of liver metastases- Alkaline phosphatase \> 2.5 X upper normal limit or 5 X upper normal limit in the case of liver metastases or \> 10 X upper normal limit in the case of bone disease. * Prior therapy with Taxotere or Epirubicin is excluded.
References
Publications (1)
- RESULTLim JY, Cho JY, Paik YH, Lee DK, Lee SI, Park HJ, Lee SJ, Lee KS, Yoon DS, Choi SH. Salvage chemotherapy with docetaxel and epirubicin for advanced/metastatic gastric cancer. Oncology. 2007;73(1-2):2-8. doi: 10.1159/000120027. Epub 2008 Mar 10. PMID 18332648