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A Randomized, Double Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA) in Combination With Gemcitabine and Cisplatin Versus Placebo in Combination With Gemcitabine and Cisplatin in Chemotherapy Naive Patients With Advanced (Stage III or IV) Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Randomized, Double Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA) in Combination With Gemcitabine and Cisplatin Versus Placebo in Combination With Gemcitabine and Cisplatin in Chemotherapy Naive Patients With Advanced (Stage III or IV) Non-Small Cell Lung Cancer


OBJECTIVES: I. Compare the 1 year survival rate, time to worsening of disease related
symptoms, and progression free survival in chemotherapy naive patients with stage IIIB or IV
non-small cell lung cancer treated with one of two doses of ZD 1839 or placebo combined with
gemcitabine and cisplatin.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are randomized to one of three treatment arms. Patients receive gemcitabine and cisplatin
combined with lower dose oral ZD 1839 (arm I), higher dose oral ZD 1839 (arm II), or placebo
(arm III).

PROJECTED ACCRUAL: A total of 1,029 patients (343 per arm) will be accrued for this study.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ron Staugarrd

Investigator Role:

Study Chair

Investigator Affiliation:

AstraZeneca

Authority:

United States: Federal Government

Study ID:

CDR0000068064

NCT ID:

NCT00006048

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

AstraZeneca Pharmaceuticals LPWilmington, Delaware  19850-5437