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

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

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxaliplatin, 5-fluorouracil

Drug

5FU 500 mg/m² per week in IV bolus infusion during 30 min AF 20mg/m²/week in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg/m² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest.

Other names: Eloxatin, 5FU

Primary outcomes

Response rate - RECIST criteria (unidimensional)

Time frame: During the study conduct

Secondary outcomes

Progression-free Survival (PFS)

Time frame: During the study conduct

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Important dates

Study start: 2002
Study completion: 2004
First posted: Feb 11, 2008
Registry last updated: Mar 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed