NCT00510107

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stomach Neoplasm
• Stage IV
• Recurrent

Interventions

Type	Name	Description
DRUG	oxaliplatin	oxaliplatin 120 mg/m2 will be given on day 1.
DRUG	Cisplatin	Cisplatin 60 mg/m2 will be given on day 1.

Timeline

• Start date: 2007-07-01
• Completion: 2009-07-01
• First posted: 2007-08-01
• Last updated: 2007-08-01

Locations

1 site across 1 country: South Korea