The comparative effect of combination chemotherapy with Paclitaxel (Taxol) and Gemcitabine vs Taxol and Vinorelbine on survival in non-operable non-small cell lung cancer stage IIIBw and IV, PS : 0, 1. A Phase III randomized study.

Hellenic Cooperative Oncology Group0 sites441 target enrollmentNovember 4, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 4, 2009

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Hellenic Cooperative Oncology Group

•Histologically proven inoperable or recurrent or metastatic NSCLC stage IIIBw and IV. Biopsy, fine needle aspiration or sputum cytology will be used to obtain the samples.
•Performance status 0, 1 of the Eastern Cooperative Oncology Group (ECOG) scale .
•Measurable disease outside prior radiotherapy ports required , unless subsequent progression is documented .
•Stable brain metastases .
•Prior surgery or radiotherapy is allowed .
•Age \> 18 years .
•Life expectancy at least 12 weeks.
•White Blood Cells (WBC) \> 4\.000/ml or platelets \> 100\.000/ml, Bilirubin \< 1\.2 mg/dl, gamma\-glutamyltranspeptidase, alkaline phosphatase (ALP) normal, serum creatinine \< 1\.4 mg/dl and creatinine clearance \> 60 ml/min.
•Informed consent has to be signed.

•Past or current history of neoplasm, except for Basal cell carcinoma of the skin or carcinoma in situ of the cervix.
•Previous treatment with chemotherapy for recurrent or metastatic disease.
•History of atrial or ventricular arrhythmias, congestive heart failure even if medically controlled. Documented myocardial infarction.
•Pre – existing motor or sensory neurotoxicity grade \>2 according to World Health Organisation (WHO) scale (intolerable paresthesias and/or marked motor loss , or worse).
•Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment .