Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer

Sponsor

Japan Multinational Trial Organization (Other)

Overall Status

Completed

CT.gov ID

NCT00104793

Collaborator

(none)

Enrollment

Locations

65.1

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin Drug: irinotecan hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

Primary

Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin.

Secondary

Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Nov 1, 2008

Outcome Measures

Primary Outcome Measures

Response []

Secondary Outcome Measures

Survival []
Progression-free survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed small cell lung cancer
Extensive stage disease
Newly diagnosed, treatment-naive disease
At least 1 unidimensionally measurable lesion
No massive pleural or pericardial effusion by chest CT scan
Manageable effusions allowed

PATIENT CHARACTERISTICS:

Age

Over 18

Performance status

ECOG 0-2

Life expectancy

More than 3 months

Hematopoietic

WBC ≥ 3,000/mm^3
Absolute granulocyte count ≥ 1,500/mm^3
Hemoglobin ≥ 9.0 g/dL

Hepatic

ALT or AST ≤ 2 times upper limit of normal
Bilirubin ≤ 1.5 mg/dL

Renal

Creatinine normal

Cardiovascular

No myocardial infarction within the past year
No uncontrolled hypertension
No unstable angina
No congestive heart failure
No ventricular arrhythmia requiring medical intervention
No other serious cardiovascular disease

Pulmonary

Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg
No interstitial pneumonitis or pulmonary fibrosis by chest x-ray

Other

Not pregnant or nursing
No uncontrolled diabetes
No severe infection
No paralytic or obstructive ileus
No serious diarrhea
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy to the chest
Other prior radiotherapy allowed

Surgery

At least 2 weeks since prior surgery and recovered

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Hospital Organization - Dohoku National Hospital	Asahikawa	Hokkaido	Japan	070-0901
2	Fujisawa City Hospital	Fujisawa	Kanagawa	Japan	251-8550
3	Kurashiki Central Hospital	Kurashiki-shi	Okayama	Japan	710-8602
4	Osaka General Medical Center	Osaka-shi	Osaka	Japan	558-0056
5	National Hospital Organization - Osaka National Hospital	Sakai	Osaka	Japan	591-8555
6	Takatsuki Red Cross Hospital	Takatsuki	Osaka	Japan	569-1096
7	Yao Tokusyu-kai General Hospital	Yao	Osaka	Japan	561-0072
8	Gunma Cancer Center	Gunma		Japan	373-8550
9	National Hospital Organization - Medical Center of Kure	Hiroshima		Japan	737-0023
10	Osaka Kosei Nenkin Hospital	Osaka		Japan	553-0003
11	Tokyo Medical and Dental University	Tokyo		Japan	113-8519