Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer

Study Overview
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Brief Summary
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This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel, Oxaliplatin and de Gramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.

Detailed Description
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Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks

Official Title
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Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer

Conditions
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Docetaxel, Oxaliplatin and Fluorouracil

Intervention / Treatment
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* Drug: Docetaxel, Oxaliplatin and 5-Fu


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2 Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination At least 3 weeks since last major surgery At least 12 months since last adjuvant chemotherapy At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields Patients with reproductive potential must use effective BC Required Screening Laboratory Criteria: Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min A probable life expectancy of at least 6 months Exclusion Criteria: Brain metastases Female of childbearing potential, pregnancy test is positive Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer Active infection Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator History of grade 3 or 4 toxicity to fluoropyrimidines

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel, Oxaliplatin and 5-Fu<br>Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks | Drug: Docetaxel, Oxaliplatin and 5-Fu<br>* To investigate the triplet regimen in the first-line therapy of advanced chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 2 years |