Clinical trial NCT02289378: Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
Official title: Dose-dense Biweekly Docetaxel, Oxaliplatin and 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Docetaxel, Oxaliplatin and Fluorouracil
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Response rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affilated Hospital of Sun Yat-sen University
name: Ping Lan, MD
role: STUDY_CHAIR
References: