Status:
COMPLETED
Amrubicin and Irinotecan in Treating Patients With Recurrent or Relapsed Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
Japan Multinational Trial Organization
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as amrubicin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when combined with irinotecan in patients with recurrent or relapsed extensive stage small cell lun...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer
- Extensive stage disease
- Recurrent or relapsed disease after 1-2 prior chemotherapy and/or radiotherapy regimens
- No unmanageable massive pleural effusion or pericardial effusion by chest CT scan
- No symptomatic brain metastasis
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- More than 3 months
- Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 8.5 g/dL
- Hepatic
- ALT and AST ≤ 2 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
- Renal
- Creatinine normal
- Cardiovascular
- No uncontrolled hypertension
- No unstable angina
- No congestive heart failure
- No myocardial infarction within the past year
- No ventricular arrhythmia requiring medical intervention
- No other serious cardiovascular disease
- Pulmonary
- Arterial oxygen pressure (PaO\_2) ≥ 70 torr
- No interstitial pneumonitis or pulmonary fibrosis by chest x-ray
- Gastrointestinal
- No serious diarrhea
- No paralytic or obstructive ileus
- Other
- Not pregnant or nursing
- No uncontrolled diabetes
- No severe infectious disorder
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- No prior anthracycline or its derivatives at \> the upper dose limit (e.g., daunorubicin ≥ 25 mg/kg, doxorubicin ≥ 500 mg/m\^2, or epirubicin ≥ 900 mg/m\^2)
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00132054
Start Date
May 1 2004
End Date
November 1 2008
Last Update
May 30 2013
Active Locations (7)
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1
Gunma Cancer Center
Gunma, Japan, 373-0828
2
National Hospital Organization - Dohoku National Hospital
Hokkaido, Japan, 070-0901
3
Kyoto University Hospital
Kyoto, Japan, 606-8501
4
Kitano Hospital
Osaka, Japan, 530-8480