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Oxaliplatin in Gastric Cancer

Primary Purpose

Stomach Neoplasms

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oxaliplatin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    December 7, 2005
    Last Updated
    November 5, 2010
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00263354
    Brief Title
    Oxaliplatin in Gastric Cancer
    Official Title
    Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2003 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stomach Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Oxaliplatin
    Primary Outcome Measure Information:
    Title
    To evaluate response rate according to RECIST criteria
    Title
    To evaluate the progression-free survival in the ITT population
    Secondary Outcome Measure Information:
    Title
    To evaluate the overall survival in the ITT population
    Title
    To investigate safety using NCI-CTC criteria version 2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jesus M. Ruiz, MD
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Oxaliplatin in Gastric Cancer

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