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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.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00611507
First received: January 28, 2008
Last updated: March 24, 2008
Last verified: March 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response rate - RECIST criteria (unidimensional) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

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

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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611507

Locations
Colombia
Sanofi-Aventis
Bogota, Colombia
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Juan Carlos Gomez Sanofi
  More Information

No publications provided

Responsible Party: Juan Carlos Gomez/Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00611507     History of Changes
Other Study ID Numbers: L_8107
Study First Received: January 28, 2008
Last Updated: March 24, 2008
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Oxaliplatin
Leucovorin
Folic Acid
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on May 23, 2013