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
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms
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
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Response rate - RECIST criteria (unidimensional)
Secondary Outcome Measures
Progression-free Survival (PFS)
Full Information
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
No
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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