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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

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ClinicalTrials.gov Identifier: NCT00611507
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : March 25, 2008
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Brief Summary:
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 or disease Intervention/treatment Phase
Stomach Neoplasms Drug: Oxaliplatin, 5-Fluorouracil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2002
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611507

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Bogota, Colombia
Sponsors and Collaborators
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Study Director: Juan Carlos Gomez Sanofi
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Responsible Party: Juan Carlos Gomez/Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00611507    
Other Study ID Numbers: L_8107
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: March 25, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs