Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | Over 18 | Other | JMTO-LC02-02 NCT00104793 |
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.
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
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
55A total of 55 patients will be accrued for this study.
Outcomes
Primary Outcome(s)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 Lead Organizations
Japan and Multinational Clinical Trial Organization
 | | | ||
| Tadashi Mio, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer | |
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| Trial Start Date | 2003-06-01 | |
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| Trial Completion Date | 2007-02-22 | |
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| Registered in ClinicalTrials.gov | NCT00104793 | |
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| Date Submitted to PDQ | 2005-01-11 | |
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| Information Last Verified | 2007-10-14 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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