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

Stomach Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611507
• Other study ID #: L_8107
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2008
• Last updated: March 24, 2008
• Start date: November 2002
• Est. completion date: April 2004

Study information

• Verified date: March 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Colombia	Sanofi-Aventis	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate - RECIST criteria (unidimensional)		During the study conduct	No
Secondary	Progression-free Survival (PFS)		During the study conduct	Yes