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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
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasm
Stage IV
Recurrent
 Drug: oxaliplatin
Drug: Cisplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • response rate

Secondary Outcome Measures:
  • safety

Estimated Enrollment: 90
Study Start Date: July 2007
Estimated Study Completion Date: July 2009
Arms Assigned Interventions
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.
 Drug: Cisplatin
Cisplatin 60 mg/m2 will be given on day 1.
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.
 Drug: oxaliplatin
oxaliplatin 120 mg/m2 will be given on day 1.
Other Name: Eloxatin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510107

Contacts
Contact: Dong Bok Shin, MD, PhD 82 32 460 3682 dbs@gilhospital.com

Locations
Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405 760
Sponsors and Collaborators
Gachon University Gil Medical Center
Sanofi
Investigators
Principal Investigator: Se Hoon Park, MD Gachon University Gil Medical Center, Incheon, Korea
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00510107     History of Changes
Other Study ID Numbers: GMO-GI-72
Study First Received: July 31, 2007
Last Updated: July 31, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Oxaliplatin
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013