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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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stomach Neoplasms

Intervention: Oxaliplatin, 5-Fluorouracil (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Juan Carlos Gomez, Study Director, Affiliation: Sanofi


This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer

Clinical Details

Official title: 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

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

Primary outcome: Response rate - RECIST criteria (unidimensional)

Secondary outcome: Progression-free Survival (PFS)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Sanofi-Aventis, Bogota, Colombia
Additional Information

Starting date: November 2002
Last updated: March 24, 2008

Page last updated: August 20, 2015

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