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Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC

NCT ID: NCT00510107

Last Updated: 2007-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Stomach Neoplasm Stage IV Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Cisplatin 60 mg/m2 will be given on day 1.

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.

Group Type EXPERIMENTAL

oxaliplatin

Intervention Type DRUG

oxaliplatin 120 mg/m2 will be given on day 1.

Interventions

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oxaliplatin

oxaliplatin 120 mg/m2 will be given on day 1.

Intervention Type DRUG

Cisplatin

Cisplatin 60 mg/m2 will be given on day 1.

Intervention Type DRUG

Other Intervention Names

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Eloxatin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Se Hoon Park, MD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center, Incheon, Korea

Locations

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Gachon University Gil Medical Center

Incheon, Incheon, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Bok Shin, MD, PhD

Role: CONTACT

[email protected]
82 32 460 3682

Other Identifiers

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GMO-GI-72

Identifier Type: -

Identifier Source: org_study_id