Status:
COMPLETED
Docetaxel and Oxaliplatin in Gastric Cancer
Lead Sponsor:
Sanofi
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chem...
Detailed Description
The purpose of this study (Part II) was to evaluate the time to progression in the 3 arms at an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot (Part I) phase study. The e...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically proven gastric adenocarcinoma, including adenocarcinoma of the gastro-oesophageal junction
- Metastatic or locally recurrent disease
- Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin, epirubicin is allowed provided that the patient has relapsed \> 12 months after the end of the chemotherapy
- Performance status Karnofsky index \> 70
- Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil Count ≥2.0 10\^9/L, platelets ≥100 x 10\^9/L
- Blood chemistry within 7 days before randomization:Total bilirubin ≤1x Upper Normal Limit(UNL), Aspartate Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase SGOT) and Alanine Aminotransferase (ALT)Serum Glutamate Pyruvate Transaminase(SGPT) ≤2.5xUNL, alkaline phosphatase ≤ 5x UNL, provided that AST or ALT \> 1.5 x UNL is not associated with alkaline phosphatase \> 2.5 x UNL; creatinine ≤1.25x UNL or 1.25x UNL \< creatinine ≤1.5x UNL and calculated/measured creatinine clearance ≥60 ml/min)
- Measurable and/or evaluable metastatic disease
- Exclusion criteria:
- Any prior palliative chemotherapy
- Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse Events grade≥2
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00382720
Start Date
September 1 2006
End Date
April 1 2010
Last Update
January 7 2013
Active Locations (12)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
2
Sanofi-Aventis Administrative Office
Diegem, Belgium
3
Sanofi-Aventis Administrative Office
Paris, France
4
Sanofi-Aventis Administrative Office
Frankfurt, Germany