Status:
COMPLETED
Weekly Docetaxel and Four Weekly Carboplatin in Non-small Cell Lung Cancer Carbo-Tax
Lead Sponsor:
Sanofi
Conditions:
Lung Neoplasms
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is: * to assess the efficacy of the combination in terms of Objective (clinical and radiological) Response Rate * to assess the time to progression of the disease; assess th...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed inoperable locally advanced or metastatic non-small cell lung cancer
- ECOG Performance Status is 0-2
- At least one measurable lesion in two dimensions by means of CT scan
- No brain metastases
- No prior chemotherapy for this malignancy,
- Acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance measured in 24 hours urine ≥ 60 mL/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 2.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)
Exclusion
- Concomitant use of another anti-cancer therapy
- Chemotherapy, radiotherapy or curative surgery
- Evidence of intracerebral metastasis
- Unstable medical condition that makes the patient to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural or peritoneal effusion; or presence of serious uncontrolled infection, diarrhea, ileus, interstitial pneumonia, pulmonary fibrosis.
- Presence of other tumours different from basal cell carcinoma of the skin, with disease free survival less then 3 years.
- Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
- Social or psychological condition that render the patient inadequate for the follow-up of the study
- Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00826852
Start Date
October 1 2003
End Date
July 1 2009
Last Update
July 27 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)