A phase II randomised study comparing the clinical benefit between Paclitaxel (Taxol) and oral Vinorelbine (Navelbine) in patients with stage IIIBw - IV non-small cell lung cancer (NSCLC), performance status (PS) 2

Hellenic Cooperative Oncology Group0 个研究点目标入组 92 人开始时间: 2010年1月8日最近更新: 2020年1月13日

适应症

试验速览

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•Histologic proof of inoperable, recurrent or metastatic non-small cell lung cancer (NSCLC). Fine needle aspiration or sputum cytology will be used to obtain the samples.
•Females of child – bearing potential must have a negative serum or urine pregnancy test within 48 hours prior to enrolment in the study .
•Performance status 2 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 and over .
•Life expectancy at least 12 weeks.
•White Blood Cells (WBC) > 4.000/ml or platelets > 100.000/ml , bilirubin < 1.2 mg/dl, serum glutamic pyruvic transaminase (SGPT), gamma-glutamyltranspeptidase, alkaline phosphatase (ALP) normal, creatinine < 1.4 mg/dl or creatinine clearance > 70 ml/min.
•Informed consent has to be obtained.

•Past or current history of neoplasm other than the entry diagnosis , except for curatively treated non melanoma skin cancer or carcinoma in situ of the cervix
•Pregnant or nursing females or not practising adequate methods of contraception
•Previous treatment with chemotherapy for recurrent or metastatic disease
•Congestive heart failure . Documented myocardial infarction within the last 6 months
•Pre – existing motor or sensory neurotoxicity grade > - 2 according to World Health Organization (WHO) criteria (intolerable paraesthesia and/or marked motor loss , or worse)
•Unstable brain metastases
•Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment , including prior allergic reactions to drugs containing cremophor , such as teniposide or cyclosporin .

发起方

Hellenic Cooperative Oncology Group