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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263354

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jesus M. Ruiz, MD Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00263354     History of Changes
Other Study ID Numbers: L_8915
Study First Received: December 7, 2005
Last Updated: November 5, 2010
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014