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Oxaliplatin in Gastric Cancer
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00263354
  Purpose

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


Condition Intervention Phase
Stomach Neoplasms
Drug: Oxaliplatin
Phase II

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To evaluate response rate according to RECIST criteria
  • To evaluate the progression-free survival in the ITT population

Secondary Outcome Measures:
  • To evaluate the overall survival in the ITT population
  • To investigate safety using NCI-CTC criteria version 2

Estimated Enrollment: 20
Study Start Date: October 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263354

Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Jesus M. Ruiz, MD Sanofi-Aventis
  More Information

clinicalstudyresults.org  This link exits the ClinicalTrials.gov site

Study ID Numbers: L_8915
Study First Received: December 7, 2005
Last Updated: March 27, 2008
ClinicalTrials.gov Identifier: NCT00263354  
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Study placed in the following topic categories:
Oxaliplatin
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil
Stomach Neoplasms
Leucovorin
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009