Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Istituto Nazionale per lo Studio e la Cura dei Tumori
Collaborator:
NCIC Clinical Trials Group
Treatments:
Cisplatin
Gemcitabine
Vinorelbine
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven non-small cell lung cancer
Stage IV OR Stage IIIB with supraclavicular lymph node metastases and/or pleural effusion
that is not curable with radiotherapy Measurable or evaluable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: Under 70 Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Neutrophil count at least 2000/mm3 Platelet count at least
100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: (Unless caused by liver metastases)
Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT or SGPT no greater
than 1.25 times ULN Renal: Creatinine no greater than 1.25 times ULN Other: No prior or
concurrent malignancy except basal or squamous cell skin cancer or carcinoma in situ of the
cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
Concurrent palliative radiotherapy allowed Surgery: Not specified