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Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Gachon University Gil Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT00510107
First received: July 31, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted

July 31, 2007
July 31, 2007
July 2007
Not Provided
response rate
Same as current
No Changes Posted
safety
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stomach Neoplasm
  • Stage IV
  • Recurrent
  • Drug: oxaliplatin
    oxaliplatin 120 mg/m2 will be given on day 1.
    Other Name: Eloxatin
  • Drug: Cisplatin
    Cisplatin 60 mg/m2 will be given on day 1.
  • Active Comparator: 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: Drug: Cisplatin
  • Experimental: 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: Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
July 2009
Not Provided

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
Both
18 Years to 75 Years
No
Contact: Dong Bok Shin, MD, PhD 82 32 460 3682 dbs@gilhospital.com
Korea, Republic of
 
NCT00510107
GMO-GI-72
No
Not Provided
Gachon University Gil Medical Center
Sanofi
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
Gachon University Gil Medical Center
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP