Overview

Vinorelbine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating older patients who have stage IIIB or stage IV non-small cell lung cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Treatments:
Vinblastine
Vinorelbine
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB or IV non-small cell lung
cancer Measurable disease At least 1 lesion that is 2.0 cm or more in longest diameter CNS
metastases allowed if previously treated and clinically stable for at least 8 weeks prior
to study No meningeal carcinomatosis Participation in translational research component of
this study is mandatory

PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10.0
g/dL Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 2.0
mg/dL Renal: Creatinine no greater than 2 times upper limit of normal Other: No dysphagia
or inability to swallow capsules intact No peripheral neuropathy grade 2 or greater No
other significant medical condition that would preclude study No active infection within
the past 2 weeks No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for this disease within the past 5 years Endocrine therapy: Not specified
Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy
to more than 25% of bone marrow No prior radiotherapy to measurable lesion unless
documented progression after therapy No concurrent radiotherapy, including palliative
radiotherapy Surgery: At least 3 weeks since prior major surgery