A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer

March 24, 2008 updated by: Sanofi
This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven gastric or gastroesophagic junction adenocarcinoma
  • Measurable disease at least in a unidimensional manner. If a unique metastasis constitutes the only disease symptom, histological confirmation will be required
  • Metastatic or locally non-surgical primary gastric cancer
  • Recurrent gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant chemo-radiotherapy of at least 6 months
  • Serum bilirubin< 2 mg/dl
  • Serum creatinine < or =to 2 times normal superior limit
  • Absolute neutrophil count > or =to 2000/dl
  • Platelet count > or =to 100000/dl
  • Hemoglobin > or =to 10 g/dl
  • AST/ALT < or =to 2.5 times normal superior institutional limit
  • Alkaline phosphatase < or =to 5 times the normal superior institutional limit
  • Age > 18 years
  • Performance Status ECOG 0-2
  • Written informed consent signed and dated

Exclusion Criteria:

  • Symptomatic sensory peripheral neuropathy
  • Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial hypertension)
  • Any other malignancy diagnosed within 5 years previous to the gastric cancer, with the exception of " in situ " cervix carcinoma or non-melanoma skin cancer
  • Concomitant anti-tumoral treatment
  • Cerebral metastases
  • Unstable heart disease, even though under treatment
  • Myocardial infarction within the last 6 months
  • Pregnancy or nursing (or women in reproductive life without adequate contraception)
  • Significant neurological or psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate - RECIST criteria (unidimensional)
Time Frame: During the study conduct
During the study conduct

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival (PFS)
Time Frame: During the study conduct
During the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

March 25, 2008

Last Update Submitted That Met QC Criteria

March 24, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_8107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stomach Neoplasms

Clinical Trials on Oxaliplatin, 5-Fluorouracil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe