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A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Stomach Neoplasms

Thank you

Trial Information

A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer


Inclusion Criteria:



- Histologically proven gastric or gastroesophagic junction adenocarcinoma

- Measurable disease at least in a unidimensional manner. If a unique metastasis
constitutes the only disease symptom, histological confirmation will be required

- Metastatic or locally non-surgical primary gastric cancer

- Recurrent gastric cancer after local and/or systemic treatment with a post-surgical
period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant
chemo-radiotherapy of at least 6 months

- Serum bilirubin< 2 mg/dl

- Serum creatinine < or =to 2 times normal superior limit

- Absolute neutrophil count > or =to 2000/dl

- Platelet count > or =to 100000/dl

- Hemoglobin > or =to 10 g/dl

- AST/ALT < or =to 2.5 times normal superior institutional limit

- Alkaline phosphatase < or =to 5 times the normal superior institutional limit

- Age > 18 years

- Performance Status ECOG 0-2

- Written informed consent signed and dated

Exclusion Criteria:

- Symptomatic sensory peripheral neuropathy

- Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial
hypertension)

- Any other malignancy diagnosed within 5 years previous to the gastric cancer, with
the exception of " in situ " cervix carcinoma or non-melanoma skin cancer

- Concomitant anti-tumoral treatment

- Cerebral metastases

- Unstable heart disease, even though under treatment

- Myocardial infarction within the last 6 months

- Pregnancy or nursing (or women in reproductive life without adequate contraception)

- Significant neurological or psychiatric disorders

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate - RECIST criteria (unidimensional)

Outcome Time Frame:

During the study conduct

Safety Issue:

No

Principal Investigator

Juan Carlos Gomez

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Study ID:

L_8107

NCT ID:

NCT00611507

Start Date:

November 2002

Completion Date:

April 2004

Related Keywords:

  • Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms

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