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Oxaliplatin in Gastric Cancer

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00263354
First received: December 7, 2005
Last updated: November 5, 2010
Last verified: August 2010
History of Changes

December 7, 2005
November 5, 2010
October 2003
July 2006   (final data collection date for primary outcome measure)
  • To evaluate response rate according to RECIST criteria
  • To evaluate the progression-free survival in the ITT population
Not Provided
Complete list of historical versions of study NCT00263354 on ClinicalTrials.gov Archive Site
  • To evaluate the overall survival in the ITT population
  • To investigate safety using NCI-CTC criteria version 2
Not Provided
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Oxaliplatin in Gastric Cancer
Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.

To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasms
Drug: Oxaliplatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2006
July 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00263354
L_8915
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Sanofi
Not Provided
Study Director: Jesus M. Ruiz, MD Sanofi
Sanofi
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP