Status:
COMPLETED
Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Japan Multinational Trial Organization
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Givi...
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 *...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00104793
Start Date
June 1 2003
End Date
November 1 2008
Last Update
May 30 2013
Active Locations (11)
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1
Gunma Cancer Center
Gunma, Gunma, Japan, 373-8550
2
National Hospital Organization - Dohoku National Hospital
Asahikawa, Hokkaido, Japan, 070-0901
3
Fujisawa City Hospital
Fujisawa, Kanagawa, Japan, 251-8550
4
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, Japan, 710-8602