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

NCT00611507 | Completed Phase 2

• 1 other identifier: L_8107
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Response rate - RECIST criteria (unidimensional)

  During the study conduct

Secondary Outcomes (1)

• Progression-free Survival (PFS)

  During the study conduct

Interventions

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.

Also known as: Eloxatin, 5FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bogotá, Colombia

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Juan Carlos Gomez

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 11, 2008
• Study Start: November 1, 2002
• Study Completion: April 1, 2004
• Last Updated: March 25, 2008

Record last verified: 2008-03

Locations

CO (1)