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
- Conditions
- Cancer - Lung - Non small cellNon-Small Cell Lung Canceron-Small Cell Lung Cancer
- Registration Number
- ACTRN12610000020088
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 92
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 .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Benefit[Clinical benefit questionnaire will be completed by the end of the 2nd and 4th cycle of chemotherapy by the treatment physician]
- Secondary Outcome Measures
Name Time Method Survival[This outcome is assessed using clinical data records at the end of 4th cycle, then every 2 months for 1 year and every 4 months for the 2nd year thereafter.];Response[Patient will be fully evaluated with computed tomography (CT) scan, bone scan, X-ray, full blood tests and any other tests which are indicated following the 2nd and 4th cycle of chemotherapy];Toxicity[Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc. after each cycle];Time to Progression[Progression is assessed by physical examination, laboratory evaluation of hematology and biochemistry and imaging methods including computed tomography (CT) scan, bone scan, X-ray etc. It is assessed every 4 months for the 1st year and for the 2nd year thereafter.]