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 - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00611507

Purpose

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

Condition	Intervention	Phase
Stomach Neoplasms	Drug: Oxaliplatin, 5-Fluorouracil	Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Response rate - RECIST criteria (unidimensional) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free Survival (PFS) [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]

Enrollment:	21
Study Start Date:	November 2002
Study Completion Date:	April 2004

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611507

Locations

Colombia
Sanofi-Aventis
Bogota, Colombia

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Juan Carlos Gomez

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Juan Carlos Gomez/Study Director )
Study ID Numbers:	L_8107
Study First Received:	January 28, 2008
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00611507
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Study placed in the following topic categories:

Oxaliplatin
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Fluorouracil
Stomach Neoplasms
Leucovorin
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 15, 2009