Status:
UNKNOWN
Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Docetaxel, Oxaliplatin and Fluorouracil
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02289378
Start Date
November 1 2014
End Date
October 1 2017
Last Update
November 14 2014
Active Locations (1)
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1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655