Overview

ZD 1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. ZD 1839 may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is more effective with or without ZD 1839 for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without ZD 1839 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:
AstraZeneca
Treatments:
Cisplatin
Gefitinib
Gemcitabine
Criteria
DISEASE CHARACTERISTICS: Histologically proven non-small cell lung cancer Stage III disease
that is not curable with surgery or radiotherapy OR Stage IV disease Chemotherapy naive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 WBC at least
4,000/mm3 Hepatic: ALT and AST less than 2.5 times upper limit of normal (ULN) (less than 5
times ULN if liver metastasis present) Bilirubin less than 1.25 times ULN Renal: Creatinine
less than 1.5 times ULN Creatinine clearance greater than 60 mL/min Cardiovascular: No
evidence of severe or uncontrolled cardiovascular disease Pulmonary: No evidence of severe
or uncontrolled pulmonary disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: No concurrent systemic endocrine therapy that is known
to have an effect on non-small cell lung cancer Radiotherapy: See Disease Characteristics
Prior localized irradiation allowed Surgery: See Disease Characteristics Prior surgery
allowed Other: No concurrent drugs with known significant cytochrome P450 3A4 inhibitory
effects (e.g., ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem,
verapamil)