Overview

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

Status:
Completed

Trial end date:
2007-06-01

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. Giving drugs in different ways may kill more tumor cells. It is not yet known whether giving vinorelbine by mouth or infusion is more effective in treating non- small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

GlaxoSmithKline

Treatments:

Vinorelbine

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB or IV
non-small cell lung cancer not amenable to combination chemotherapy, curative surgery, or
radiotherapy Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet
count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than
1.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN Alkaline phosphatase
less than 5 times ULN (except in cases of bone or liver metastases) Renal: Creatinine no
greater than 1.5 times ULN Cardiovascular: No unstable or uncontrolled cardiac disease
Pulmonary: No history of recurrent aspiration pneumonitis within the past 3 months Other:
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception during and for 9 days after study Able to swallow capsules intact No active
infection within the past 2 weeks No unstable or uncontrolled medical conditions No other
prior malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ
of the cervix No history of peripheral neuropathy with severity greater than CALGB grade 1

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunologic therapy At least 1 week
since prior hematopoietic growth factors or other blood products Chemotherapy: See Disease
Characteristics No prior chemotherapy No other concurrent chemotherapy Endocrine therapy:
Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior
radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior surgery
Other: At least 4 weeks since prior investigational device or drug No other concurrent
anticancer therapy No other concurrent investigational device or drug