Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

NCT00259402 | Completed Phase 2

• 1 other identifier: EFC_7127
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

• To determine the activity and efficacy of the schema specified as dose regimen
• To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Efficacy endpoints include tumor response, progression free and overall survival.

  Throughout the whole study

Secondary Outcomes (1)

• Safety endpoints include summary of adverse events assessed by history, physical exams and laboratory evaluations.

  Throughout the whole study duration

Study Arms (1)

Oxaliplatin

EXPERIMENTAL

Drug: Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU)

Interventions

Oxaliplatin + cisplatin + 5-Fluorouracil (5-FU) DRUG

OXALIPLATIN 60 mg/m2/d, CISPLATIN 55 mg/m2/d, 5-FU 600 mg/m2/d with dose range and followed by radiotherapy

Oxaliplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG 0-1
• Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease;
• No previous treatment with chemotherapy or radiotherapy
• Measurable lesion (uni or bidimensional)

You may not qualify if:

• Creatinin clearance \<50 mL/min
• Total bilirubin \>1.5\*ULN (Upper Limit of Normal)
• AST/ALT \> 2.5\*ULN
• Total White Blood Cell \<1.500.000/mL
• Platelet count \<100.000.000/mL
• symptomatic sensitive peripheral neuropathy
• pregnant or breast-feeding women
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Oxaliplatin; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• José Mª Taboada

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: November 29, 2005
• Study Start: February 1, 2000
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

ES (1)