Docetaxel and Epirubicin in Advanced Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Intervention: Docetaxel and epirubicin
Intervention MeSH terms: Docetaxel; Epirubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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.