A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

316

Participants

Timeline

Start Date

April 30, 2003

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Gastric Cancer
Interventions
DRUG

5-Fluorouracil

Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m\^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.

DRUG

Capecitabine

Participants will receive oral capecitabine, 1000 mg/m\^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.

DRUG

Cisplatin

Participants will receive cisplastin, 80 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.

Trial Locations (45)

13

Lima

852

Hong Kong

11600

Montevideo

14000

Mexico City

14080

Mexico City

56000

Kuala Lumpur

97070

Mérida

100021

Beijing

100036

Beijing

115478

Moscow

197758

Saint Petersburg

200003

Shanghai

200092

Shanghai

200433

Shanghai

210009

Jiangsu

215006

Suzhou

250117

Shandong

300060

Tianjin

330000

Jiangxi

420029

Kazan'

430030

Hubei

450054

Ufa

510060

Guangdong

510515

Guangdong

C1264AAA

Buenos Aires

C1270AAE

Buenos Aires

S2000PBJ

Rosario

Unknown

Tegucigalpa

Bogotá

Hong Kong

Callao

14780-400

Barretos

80060-150

Curitiba

88034-000

Florianópolis

60741-420

Fortaleza

90020-090

Porto Alegre

05403-010

São Paulo

18035-300

Sorocaba

01015

Guatemala City

06726

Mexico City

83-0669

Panama City

135-170

Seoul

135-720

Seoul

138-736

Seoul

405-760

Seoul

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02563054 - A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer | Biotech Hunter | Biotech Hunter