None listed
Conditions
Brief summary
This is a phase II randomized trial in an effort to compare two single agents Paclitaxel (Taxol) vs Vinorelbine (Navelbine) in poor performance Non-small cell lung cancer (NSCLC) patients . The primary endpoint will be clinical benefit and the secondary response, toxicity, survival and time to progression.
Interventions
Patients in Group B will receive Paclitaxel (Taxol) 90 mg/m2 IV (intravenous) for 1h on days 1, 8, 15 every 4 weeks for a total of 4 cycles. H2 blocker (H2 receptor agonists) antiemetics 8mg will be given iv prior to Paclitaxel
Sponsors
Hellenic Cooperative Oncology Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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 .
Outcome results
None listed