Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
Conditions
Docetaxel, Oxaliplatin and Fluorouracil
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel, Oxaliplatin and 5-Fu
Type: Drug
Overall Status
Recruiting
Summary
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
Docetaxel 50mg/m2 Oxaliplatin 85mg/m2 5-Fu 2800mg/m2 Repeated every two weeks
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Jian Xiao, Ph D - 86-2038250745 - xiao_jian@139.com
Start Date
November 2014
Completion Date
October 2017
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Source
Sixth Affiliated Hospital, Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page