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Oxaliplatin in Gastric Cancer

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: December 7, 2005
Last updated: November 5, 2010
Last verified: August 2010
To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.

Condition Intervention Phase
Stomach Neoplasms Drug: Oxaliplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.

Resource links provided by NLM:

Further study details as provided by Sanofi:

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

Estimated Enrollment: 20
Study Start Date: October 2003
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00263354

Sponsors and Collaborators
Study Director: Jesus M. Ruiz, MD Sanofi
  More Information Identifier: NCT00263354     History of Changes
Other Study ID Numbers: L_8915
Study First Received: December 7, 2005
Last Updated: November 5, 2010

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents processed this record on August 18, 2017