- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00104793
Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Gunma, Japan, 373-8550
- Gunma Cancer Center
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Hiroshima, Japan, 737-0023
- National Hospital Organization - Medical Center of Kure
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Osaka, Japan, 553-0003
- Osaka Kosei Nenkin Hospital
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Tokyo, Japan, 113-8519
- Tokyo Medical and Dental University
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Hokkaido
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Asahikawa, Hokkaido, Japan, 070-0901
- National Hospital Organization - Dohoku National Hospital
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Kanagawa
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Fujisawa, Kanagawa, Japan, 251-8550
- Fujisawa City Hospital
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Okayama
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Kurashiki-shi, Okayama, Japan, 710-8602
- Kurashiki Central Hospital
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Osaka
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Osaka-shi, Osaka, Japan, 558-0056
- Osaka General Medical Center
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Sakai, Osaka, Japan, 591-8555
- National Hospital Organization - Osaka National Hospital
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Takatsuki, Osaka, Japan, 569-1096
- Takatsuki Red Cross Hospital
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Yao, Osaka, Japan, 561-0072
- Yao Tokusyu-kai General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response
|
Secondary Outcome Measures
Outcome Measure |
---|
Progression-free survival
|
Survival
|
Collaborators and Investigators
Investigators
- Study Chair: Tadashi Mio, MD, Kyoto University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Carboplatin
- Irinotecan
Other Study ID Numbers
- JMTO-LC02-02
- CDR0000415703 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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