Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC
Conditions
Stomach Neoplasm - Stage IV - Recurrent
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: oxaliplatin Type: Drug
Name: Cisplatin Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Status: Recruiting
Start Date
July 2007
Completion Date
July 2009
Sponsors
Gachon University Gil Medical Center
Source
Gachon University Gil Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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