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Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

Primary Purpose

Stomach Neoplasm, Stage IV, Recurrent

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oxaliplatin
Cisplatin
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gachon University Gil Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

safety

Full Information

First Posted
July 31, 2007
Last Updated
July 31, 2007
Sponsor
Gachon University Gil Medical Center
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00510107
Brief Title
Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC
Official Title
A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Gachon University Gil Medical Center
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm, Stage IV, Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
oxaliplatin 120 mg/m2 will be given on day 1.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 60 mg/m2 will be given on day 1.
Primary Outcome Measure Information:
Title
response rate
Secondary Outcome Measure Information:
Title
safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Bok Shin, MD, PhD
Phone
82 32 460 3682
Email
dbs@gilhospital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Hoon Park, MD
Organizational Affiliation
Gachon University Gil Medical Center, Incheon, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405 760
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

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