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A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.

NCT ID: NCT00436241

Last Updated: 2016-11-02

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-11-30

Brief Summary

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This single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

85mg/m2 iv on day 1 of each 2 week cycle

capecitabine [Xeloda]

Intervention Type DRUG

1000mg/m2 po bid on days 1-10 of each 2 week cycle

Interventions

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Oxaliplatin

85mg/m2 iv on day 1 of each 2 week cycle

Intervention Type DRUG

capecitabine [Xeloda]

1000mg/m2 po bid on days 1-10 of each 2 week cycle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* gastric cancer with unresectable locally advanced and/or metastatic disease;
* \>=1 measurable lesion;
* ambulatory, with ECOG Performance Status \>=1.

Exclusion Criteria

* previous chemotherapy (except adjuvant or neoadjuvant treatment \>=6 months prior to enrollment);
* clinically significant cardiac disease or myocardial infarction within last 12 months;
* CNS metastases;
* history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Chai Yi, , Taiwan

Site Status

Chai Yi, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Keelung, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taoyuan District, , Taiwan

Site Status

Yilan, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ML20734

Identifier Type: -

Identifier Source: org_study_id