A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer
18 Years
75 Years
Both
Stomach Neoplasm, Stage IV, Recurrent
Trial Information
A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer
Gastric cancer is the most frequently occurring malignancy in Korea, and is one of the main
causes of cancer death. While treatment options for AGC have expanded in recent years to
include newer agents such as taxanes, irinotecan and oxaliplatin, myelosuppression remains a
problem. Recently, weekly schedule of docetaxel is appealing due to limited incidence of
severe myelosuppression compared with standard 3-weekly regimen. This altered toxicity
profile suggests a potential for better tolerance and increased dose intensity.
Inclusion Criteria:
- histologically proven gastric cancer
- aged 75 years or less
- performance status 0 to 2
- no prior chemotherapy
- inoperable, recurrent, or metastatic
- normal marrow, hepatic and renal functions
Exclusion Criteria:
- active infections
- severe co-morbidities
- pregnant or lactating women
- active brain metastasis
- neuropathy of grade 2 or higher
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response rate
Principal Investigator
Se Hoon Park, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gachon University Gil Medical Center, Incheon, Korea
Authority:
Korea: Food and Drug Administration
Study ID:
GMO-GI-72
NCT ID:
NCT00510107
Start Date:
July 2007
Completion Date:
July 2009
Related Keywords:
- Stomach Neoplasm
- Stage IV
- Recurrent
- Neoplasms
- Stomach Neoplasms
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