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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

Primary Purpose

Stomach Neoplasms

Status

Completed

Phase

Phase 2

Locations

Colombia

Study Type

Interventional

Intervention

Oxaliplatin, 5-Fluorouracil

About this trial

This is an interventional treatment trial for Stomach Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

Response rate - RECIST criteria (unidimensional)

Secondary Outcome Measures

Progression-free Survival (PFS)

Full Information

NCT ID

NCT00611507

First Posted

January 28, 2008

Last Updated

March 24, 2008

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00611507

Brief 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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin, 5-Fluorouracil

Other Intervention Name(s)

Eloxatin, 5FU

Intervention Description

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.

Primary Outcome Measure Information:

Title

Response rate - RECIST criteria (unidimensional)

Time Frame

During the study conduct

Secondary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Time Frame

During the study conduct

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Carlos Gomez

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Bogota

Country

Colombia

12. IPD Sharing Statement

Learn more about this trial

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

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