Clinical trial NCT00454636: A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
Official title: Open Label, Phase II Study of Capecitabine (Xeloda®) as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-04-02
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced or metastatic gastric cancer;
* Eastern Cooperative Oncology Group (ECOG) \<=2.

Exclusion Criteria:

* previous chemotherapy (except adjuvant or neoadjuvant treatment \>=6 months prior to study);
* evidence of central nervous system (CNS) metastasis;
* history of another malignancy within the last 5 years (except for successfully treated basal cell cancer of skin, or in situ cancer of the cervix);
* clinically significant cardiac disease.

Primary outcomes:
measure: Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
timeFrame: Approximately 3.25 years
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Approximately 3.25 years
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 3.25 years
measure: Overall Survival (OS)
timeFrame: Approximately 3.25 years
measure: Duration of Response
timeFrame: Approximately 3.25 years
measure: Time to Response
timeFrame: Approximately 3.25 years
Other outcomes:
Locations:
city: Alcoy
country: Spain
state: Alicante
city: Gijon
country: Spain
state: Asturias
city: Cádiz
country: Spain
state: Cadiz
city: Jerez de La Frontera
country: Spain
state: Cadiz
city: Puerto Real
country: Spain
state: Cadiz
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Barbastro
country: Spain
state: Huesca
city: Palma De Mallorca
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Ferrol
country: Spain
state: La Coruña
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Logroño
country: Spain
state: La Rioja
city: Alcorcon
country: Spain
state: Madrid
city: Pamplona
country: Spain
state: Navarra
city: Vigo
country: Spain
state: Pontevedra
city: La Laguna
country: Spain
state: Tenerife
city: Bilbao
country: Spain
state: Vizcaya
city: Avila
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Castellon
country: Spain
city: Cordoba
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: Granada
country: Spain
city: Guadalajara
country: Spain
city: Huesca
country: Spain
city: Jaen
country: Spain
city: La Coruña
country: Spain
city: La Coruña
country: Spain
city: Leon
country: Spain
city: Lerida
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Navarra
country: Spain
city: Orense
country: Spain
city: Palencia
country: Spain
city: Pontevedra
country: Spain
city: Salamanca
country: Spain
city: Sevilla
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: