Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC - Full Text View

Sponsors and Collaborators:	Gachon University Gil Medical Center Sanofi-Aventis
Information provided by:	Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:	NCT00510107

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 II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Docetaxel Cisplatin Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer

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
1: Active Comparator 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.
2: Experimental 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.

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-Aventis

Investigators

Principal Investigator:

Se Hoon Park, MD

Gachon University Gil Medical Center, Incheon, Korea

More Information

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

Study placed in the following topic categories:

Docetaxel
Oxaliplatin
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009