Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

Sanofi

Status and phase: Completed; Phase 2

Conditions: Esophageal Neoplasms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259402

EFC_7127

Details and patient eligibility

About

• 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

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Oxaliplatin

Experimental group

Treatment:

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