Randomized Cross-over Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC. A Phase IV Study.
1. Histologically or cytologically confirmed stage IIIB or IV NSCLC.
2. Age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age
≤ 70 but ECOG PS ≥ 2
3. Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as
>20 mm with conventional techniques or as >10 mm with spiral CT scan. See section
9.2 and Appendix E for the evaluation of measurable disease.
4. Patients with asymptomatic brain metastases are eligible
5. Patients with recurrent disease after previous surgery are eligible
6. Life expectancy > 3 months
7. Patients must have normal organ and marrow function
8. Female participants of child bearing potential and male participants whose partner is
of child bearing potential must be willing to ensure that they or their partner use
effective contraception during the study and for 3 months thereafter
9. Ability to understand and the willingness to sign a written informed consent document
The participant may not enter the study if ANY of the following apply:
1. Patients who have had previous chemotherapy for lung cancer or radiotherapy on target
2. Participation in another clinical trial with any investigational agents within 30
days prior to study screening.
3. Presence of infection.
4. Preexisting clinically significant peripheral neuropathy.
5. History or evidence of malabsorption syndrome or disease that may significantly
affect gastrointestinal function.
6. Patients with known symptomatic uncontrolled brain metastases should be excluded from
this clinical trial because of their poor prognosis and because they often develop
progressive neurologic dysfunction that would confound the evaluation of neurologic
and other adverse events.
7. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to vinorelbine or other agents used in the study.
8. Presence of medical problems of sufficient severity to prevent full compliance with
9. Other known malignant neoplastic diseases in the patient's medical history with a
disease-free interval of less than 5 years (except for previously treated basal cell
carcinoma and in situ carcinoma of the uterine cervix);