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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104793
• Other study ID #: JMTO-LC02-02
• Secondary ID: CDR0000415703
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2005
• Last updated: May 29, 2013
• Start date: June 2003
• Est. completion date: November 2008

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• carboplatin

• irinotecan hydrochloride

Locations

Country	Name	City	State
Japan	National Hospital Organization - Dohoku National Hospital	Asahikawa	Hokkaido
Japan	Fujisawa City Hospital	Fujisawa	Kanagawa
Japan	Gunma Cancer Center	Gunma
Japan	National Hospital Organization - Medical Center of Kure	Hiroshima
Japan	Kurashiki Central Hospital	Kurashiki-shi	Okayama
Japan	Osaka Kosei Nenkin Hospital	Osaka
Japan	Osaka General Medical Center	Osaka-shi	Osaka
Japan	National Hospital Organization - Osaka National Hospital	Sakai	Osaka
Japan	Takatsuki Red Cross Hospital	Takatsuki	Osaka
Japan	Tokyo Medical and Dental University	Tokyo
Japan	Yao Tokusyu-kai General Hospital	Yao	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Japan Multinational Trial Organization

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Okishio K, Mio T, Kawahara M, Yoshioka H, Yanagihara K, Daimon T, Furuse K. A weekly combination of carboplatin and irinotecan for previously untreated extensive disease small-cell lung cancer, results of a minimum follow-up of 3 years: a multi-center Pha — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response			No
Secondary	Survival			No
Secondary	Progression-free survival			No