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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Stomach Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oxaliplatin, 5-Fluorouracil

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.

Intervention Type DRUG

Other Intervention Names

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Eloxatin, 5FU

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Juan Carlos Gomez

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Bogotá, , Colombia

Site Status

Countries

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Colombia

Other Identifiers

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L_8107

Identifier Type: -

Identifier Source: org_study_id