Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

Stomach Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00510107
• Other study ID #: GMO-GI-72
• Status: Recruiting
• Phase: Phase 2
• First received: July 31, 2007
• Last updated: July 31, 2007
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: July 2007
• Source: Gachon University Gil Medical Center
• Contact: Dong Bok Shin, MD, PhD
• Phone: 82 32 460 3682
• Email: dbs[@]gilhospital.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Recurrent
• Stage IV
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• oxaliplatin
oxaliplatin 120 mg/m2 will be given on day 1.
• Cisplatin
Cisplatin 60 mg/m2 will be given on day 1.

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (2)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center	Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate
Secondary	safety