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

NCT ID: NCT00104793

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2008-11-30

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.

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

carboplatin

Intervention Type: DRUG

irinotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Japan Multinational Trial Organization

OTHER

Sponsor Role: lead

Principal Investigators

Tadashi Mio, MD

Role: STUDY_CHAIR

Kyoto University Hospital

Locations

Gunma Cancer Center

Gunma, Gunma, Japan

National Hospital Organization - Dohoku National Hospital

Asahikawa, Hokkaido, Japan

Fujisawa City Hospital

Fujisawa, Kanagawa, Japan

Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken, Japan

Osaka Kosei Nenkin Hospital

Osaka, Osaka, Japan

Osaka General Medical Center

Osaka, Osaka, Japan

National Hospital Organization - Osaka National Hospital

Sakai, Osaka, Japan

Takatsuki Red Cross Hospital

Takatsuki, Osaka, Japan

Yao Tokusyu-kai General Hospital

Yao, Osaka, Japan

Tokyo Medical and Dental University

Tokyo, Tokyo, Japan

National Hospital Organization - Medical Center of Kure

Hiroshima, , Japan

Countries

Japan

References

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 Phase II trial JMTO LC02-02. Jpn J Clin Oncol. 2012 May;42(5):387-93. doi: 10.1093/jjco/hys028. Epub 2012 Mar 19.

Reference Type: RESULT

PMID: 22430871 (View on PubMed)

Other Identifiers

CDR0000415703

Identifier Type: REGISTRY

Identifier Source: secondary_id

JMTO-LC02-02

Identifier Type: -

Identifier Source: org_study_id