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Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.

Phase 2
18 Years
Not Enrolling
Stomach Neoplasms

Thank you

Trial Information

Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or Metastatic Gastric Cancer.

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate response rate according to RECIST criteria

Principal Investigator

Jesus M. Ruiz, MD

Investigator Role:

Study Director

Investigator Affiliation:



Mexico: National Institute of Public Health, Health Secretariat

Study ID:




Start Date:

October 2003

Completion Date:

July 2006

Related Keywords:

  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms