Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer

To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The primary endpoint will be the response rate.

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