Oxaliplatin in Gastric Cancer

November 5, 2010 updated by: Sanofi

Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.

To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

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:

  • ECOG performance status of 0-2.
  • Histologically proven gastric or gastro-esophageal junction adenocarcinoma.
  • At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation.
  • First line locally unresectable or metastatic gastric cancer.
  • Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months.
  • Serum bilirubin < 2 mg/dl
  • Serum creatinine < or = 2 mg/dl
  • Hemoglobin > or = 10 g/dl
  • Absolute neutrophil count > or = 2000/dl
  • Platelet count >or = 100, 000/dl
  • AST/ALT < or = 2.5 time-fold the institutional normal upper limit
  • Alkaline phosphatase < or = 5 time-fold the institutional normal upper limit
  • Imagenological evaluation of the patient at least 2 weeks prior to the drug infusion
  • Laboratory tests at least 1 week prior to the first infusion
  • Patient available for follow up and able to answer to the quality of life questionnaire

Exclusion Criteria:

  • Symptomatic sensorial peripheral neuropathy
  • Uncontrolled concomitant disease
  • Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer
  • Concomitant antitumoral treatment
  • Cerebral metastases
  • Unstable heart disease, even though in treatment
  • Myocardial infarction within the last 6 months
  • Radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate response rate according to RECIST criteria
To evaluate the progression-free survival in the ITT population

Secondary Outcome Measures

Outcome Measure
To investigate safety using NCI-CTC criteria version 2
To evaluate the overall survival in the ITT population

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

  • Study Director: Jesus M. Ruiz, MD, 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

October 1, 2003

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

December 7, 2005

First Submitted That Met QC Criteria

December 7, 2005

First Posted (Estimate)

December 8, 2005

Study Record Updates

Last Update Posted (Estimate)

November 9, 2010

Last Update Submitted That Met QC Criteria

November 5, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_8915

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.

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