Docetaxel and Oxaliplatin in Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Intervention: Docetaxel + Oxaliplatin; Docetaxel + Oxaliplatin + 5-FU; Docetaxel + Oxaliplatin + Capecitabine
Intervention description: Dose level 1 (non-optimal dose):
Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1
Dose level 2 (optimal dose):
Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1; Dose level 1 (non-optimal dose):
Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m2 as a 46-hour continuous infusion day 1.
Dose level 2 (optimal dose):
Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1.; Dose level 1 (optimal dose):
Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously.
Dose level 2 (non-optimal dose):
Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously.
Intervention MeSH terms: Docetaxel; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II study addressed the use of docetaxel in combination with oxaliplatin with or
      without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously
      untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part
      I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in
      each arm. The optimal dose was administered in the Part II study. Participants who received
      the optimal dose in each treatment arm in Part I were included in the Part II analysis
      population.

      Primary objective:

        -  To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin
           with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent
           gastric cancer previously untreated with chemotherapy for advanced disease (part II).

      Secondary objectives:

        -  To establish the safety profile.

        -  To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO)
           criteria

        -  To assess the Overall Survival (OS)
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically proven gastric adenocarcinoma, including adenocarcinoma of the
             gastro-oesophageal junction

          -  Metastatic or locally recurrent disease

          -  Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin,
             epirubicin is allowed provided that the patient has relapsed > 12 months after the end
             of the chemotherapy

          -  Performance status Karnofsky index > 70

          -  Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil
             Count ≥2.0 10^9/L, platelets ≥100 x 10^9/L

          -  Blood chemistry within 7 days before randomization:Total bilirubin ≤1x Upper Normal
             Limit(UNL), Aspartate Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase
             SGOT) and Alanine Aminotransferase (ALT)Serum Glutamate Pyruvate Transaminase(SGPT)
             ≤2.5xUNL, alkaline phosphatase ≤ 5x UNL, provided that AST or ALT > 1.5 x UNL is not
             associated with alkaline phosphatase > 2.5 x UNL; creatinine ≤1.25x UNL or 1.25x UNL <
             creatinine ≤1.5x UNL and calculated/measured creatinine clearance ≥60 ml/min)

          -  Measurable and/or evaluable metastatic disease

        Exclusion criteria:

          -  Any prior palliative chemotherapy

          -  Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse
             Events grade≥2

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.