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A Randomized, Double-Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA) in Combination With Paclitaxel and Carboplatin Versus Placebo in Combination With Paclitaxel and Carboplatin 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 Paclitaxel and Carboplatin Versus Placebo in Combination With Paclitaxel and Carboplatin 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
paclitaxel and carboplatin. II. Compare the quality of life of patients treated with these
three regimens.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are randomized to one of three treatment arms. All patients receive paclitaxel IV over 3
hours followed by carboplatin IV over 15-30 minutes on day 1. Patients receive lower dose
oral ZD 1839 (arm I), higher dose oral ZD 1839 (arm II), or placebo (arm III) twice on day
1, and then once daily thereafter. Chemotherapy repeats every 3 weeks for a maximum of 6
courses. ZD 1839 or placebo continues daily in the absence of disease progression or
unacceptable toxicity. Quality of life is assessed prior to study, then every 3 weeks until
completion of chemotherapy, then every 4 weeks until completion of oral ZD 1839 or placebo,
and then every 8 weeks thereafter. Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 1,029 patients 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 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

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:

CDR0000068065

NCT ID:

NCT00006049

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