MedTrace Logo

A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.

NCT00454636 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2016-09-29

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Cisplatin

80 mg/m2/day, intravenous (IV), every 3 weeks

DRUG

Capecitabine

1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle

DRUG

Epirubicin

50 mg/m2/day, IV, every 3 weeks

DRUG

Cisplatin

60 mg/m2/day, IV, every 3 weeks

DRUG

Capecitabine

625 mg/m2, oral, twice daily per 3-week cycle

DRUG

Oxaliplatin

130 mg/m2/day, IV, every 3 weeks

DRUG

Docetaxel

60 mg/m2/day, IV, every 3 weeks

DRUG

Capecitabine

825 mg/m2, oral, twice daily for 2 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454636 on ClinicalTrials.gov