A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Cisplatin
- Conditions
- Stomach Neoplasm
- Sponsor
- Gachon University Gil Medical Center
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- response rate
- Last Updated
- 18 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Docetaxel 35 mg/m2 will be administered on days 1 and 8. Cisplatin 60 mg/m2 will be administered on day 1 every 3 weeks.
Intervention: Cisplatin
2
Docetaxel 35 mg/m2 will be administered on days 1 and 8. Oxaliplatin 120 mg/m2 will be administered on day 1 every 3 weeks.
Intervention: oxaliplatin
Outcomes
Primary Outcomes
response rate
Secondary Outcomes
- safety