Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer
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 lung cancer.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the frequency and severity of adverse events in patients treated with this
regimen.
OUTLINE: This is a dose-escalation study of amrubicin.
Patients receive amrubicin on day 1 and irinotecan IV on days 1 and 8. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses of amrubicin until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 1/3 (or 33%) of patients experience dose-limiting toxicity. An additional 6
patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 6-30 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Tadashi Mio, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kyoto University
Authority:
United States: Federal Government
Study ID:
JMTO-LC03-03
NCT ID:
NCT00132054
Start Date:
May 2004
Completion Date:
November 2008
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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