Overview

ZD 1839 Plus 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 combination 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 III or stage IV non-small cell lung cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Gefitinib
Paclitaxel
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 Platelet count at least 100,000/mm3 Hepatic: ALT or AST no greater than 2.5 times
upper limit of normal (ULN) (no greater than 5 times ULN if liver metastasis present)
Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No evidence of severe or
uncontrolled cardiovascular disease Pulmonary: No evidence of severe or uncontrolled
pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: No concurrent therapy that may interfere with evaluation
of response 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) No concurrent use of contact lenses