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Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients


Phase 2
18 Years
75 Years
Not Enrolling
Both
Esophageal Neoplasms

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Trial Information

Phase II Open-label Single Arm Study of Oxaliplatin Combined With Cisplatin and 5FU in Advanced Esophagus Cancer Patients


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Throughout the whole study

Safety Issue:

No

Principal Investigator

José Mª Taboada

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Spain: Spanish Agency of Medicines

Study ID:

EFC_7127

NCT ID:

NCT00259402

Start Date:

February 2000

Completion Date:

October 2008

Related Keywords:

  • Esophageal Neoplasms
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms

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