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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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: January 28, 2008
Last updated: March 24, 2008
Last verified: March 2008
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

Condition Intervention Phase
Stomach Neoplasms
Drug: Oxaliplatin, 5-Fluorouracil
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response rate - RECIST criteria (unidimensional) [ Time Frame: During the study conduct ]

Secondary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: During the study conduct ]

Enrollment: 21
Study Start Date: November 2002
Study Completion Date: April 2004
Intervention Details:
    Drug: Oxaliplatin, 5-Fluorouracil
    5FU 500 mg/m² per week in IV bolus infusion during 30 min AF 20mg/m²/week in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg/m² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest.
    Other Name: Eloxatin, 5FU

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00611507

Bogota, Colombia
Sponsors and Collaborators
Study Director: Juan Carlos Gomez Sanofi
  More Information

Responsible Party: Juan Carlos Gomez/Study Director, sanofi-aventis Identifier: NCT00611507     History of Changes
Other Study ID Numbers: L_8107
Study First Received: January 28, 2008
Last Updated: March 24, 2008

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Folic Acid
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances
Hematinics processed this record on May 25, 2017