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

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Primary Purpose

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

carboplatin

gefitinib

paclitaxel

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

AstraZeneca Pharmaceuticals LP

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006049

First Posted

July 5, 2000

Last Updated

December 18, 2013

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00006049

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2001

Overall Recruitment Status

Unknown status

Study Start Date

May 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Type

Drug

Intervention Name(s)

gefitinib

Intervention Type

Drug

Intervention Name(s)

paclitaxel

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ron Staugarrd

Organizational Affiliation

AstraZeneca

Official's Role

Study Chair

Facility Information:

Facility Name

AstraZeneca Pharmaceuticals LP

City

Wilmington

State/Province

Delaware

ZIP/Postal Code

19850-5437

Country

United States

Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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