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Efficacy and Safety Study of Combination Therapy With Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status

NCT00733616 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2013-02-20

No results posted yet for this study

Summary

The purpose of the study is to determine efficacy and safety of combination therapy with adjusted-dose docetaxel-oxaliplatin-capecitabine in patients with advanced gastric adenocarcinoma and intermediate general status.(defined as ECOG 2 or weight loss 10-25% or older that 70 years and no comorbidities nor functional dependency nor geriatric syndrome)

Conditions

Interventions

DRUG

DOX: Docetaxel, oxaliplatin, Capecitabine

* Docetaxel 40 mg/m2, iv infusion 60 minutes, day 1 * Oxaliplatin 80 mg/m2, iv infusion 120 minutes, day 1 * Capecitabine 625 mg/m2, bid, oral, continuous 6 cycles, every 3 weeks Capecitabine will be given same dose (625mg/m2/bid) continuous in case no toxicity (no dose adjustment)

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

    lead OTHER

Principal Investigators

  • Fernando Rivera, MD; phD · Hospital Marques de Valdecilla. Santander. Spain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Spain

Study Locations

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Entities

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 NCT00733616 on ClinicalTrials.gov