Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC | NCT00510107

Studies
Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

NCT00510107

Sponsor

Gachon University Gil Medical Center

Status

Unknown status

Last Update Posted

Aug 1, 2007Estimated

Enrollment

90Estimated

Phase

Phase 2

Conditions

Stomach Neoplasm
Stage IV
Recurrent

Interventions

oxaliplatin
Cisplatin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Not provided

Completion Date

Jul 2009Estimated

First Submitted Date

Jul 31, 2007

First Submission Date that Met QC Criteria

Jul 31, 2007

First Posted Date

Aug 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2007

Last Update Posted Date

Aug 1, 2007Estimated

Name	Class
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxaliplatin	Drug	oxaliplatin 120 mg/m2 will be given on day 1.	2	Eloxatin

Measure	Description	Time Frame
response rate

Measure	Description	Time Frame
safety

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong Bok Shin, MD, PhD	Contact	82 32 460 3682		dbs@gilhospital.com

Overall Officials

Name	Affiliation	Role
Se Hoon Park, MD	Gachon University Gil Medical Center, Incheon, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon University Gil Medical Center	Recruiting	Incheon	Incheon	405 760	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D012008	Recurrence

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin
D002945	Cisplatin

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided