Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 18	Other	JMTO-LC02-02 NCT00104793

Objectives

Primary

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

Secondary

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

Entry 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

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

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute granulocyte count ≥ 1,500/mm³
• 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 O₂) ≥ 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

Expected Enrollment

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

Outcomes

Response

Survival
Progression-free survival

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.

Trial Contact Information

Trial Lead Organizations

Japan and Multinational Clinical Trial Organization

Tadashi Mio, MD, Protocol chair		Ph: 81-75-751-3830 Email: mio@kuhp.kyoto-u.ac.jp

Registry Information
Official Title		Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer
Trial Start Date		2003-06-01
Trial Completion Date		2007-02-22
Registered in ClinicalTrials.gov		NCT00104793
Date Submitted to PDQ		2005-01-11
Information Last Verified		2007-10-14

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