Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer
OBJECTIVES:
- Determine the response rate in patients with small cell lung cancer treated with SN-38
liposome that is dosed according to a UGT1A1-specific genotype.
- Determine the toxicity of this drug in these patients.
- Determine, preliminarily, overall and progression-free survival of patients treated
with this drug.
- Determine the quality of life of patients treated with this drug.
- Correlate UGT1A1-specific haplotypes with toxicity of this drug in these patients.
- Correlate UGT1A1-specific haplotypes with outcomes of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time
since prior treatment (previously untreated disease OR chemosensitive disease and ≥ 3 months
since prior treatment vs refractory disease OR chemoresistant disease and < 3 months since
prior treatment).
Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days
for 2 courses in the absence of disease progression or unacceptable toxicity. Patients
achieving a complete or partial response or patients with stable disease (SD) who were
previously treated before study enrollment receive up to 4 additional courses of treatment.
Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After
completion of WBRT, these patients also receive up to 4 additional courses of treatment.
Patients with disease progression to sites other than the CNS or patients with SD who were
previously untreated before study enrollment are removed from the study.
Quality of life is assessed at baseline, before each treatment course, and then annually for
3 years.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 73 patients (40 for stratum I and 33 for stratum II) will
be accrued for this study within 16-19 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer meeting 1 of the
following criteria:
- Previously untreated disease
- Extensive stage disease, as defined by any of the following:
- Metastatic disease outside of the chest
- Contralateral supraclavicular or contralateral hilar nodes that cannot
be included in a single radiation port
- Malignant pleural effusion
- Previously treated disease
- Limited or extensive stage disease
- Measurable disease
- Lesions ≥ 1 cm and < 2 cm must be measured by spiral CT scan for pre- and
post-treatment tumor assessment
- UGT1A1*28 genotype wt/wt (6/6 promoter TA repeats) OR wt/*28 (6/7 promoter TA
repeats)
- No *28/*28 (7/7 promoter TA repeats) genotype
- No mixed histology
- No uncontrolled CNS metastasis
- Previously treated, stable CNS metastasis allowed
- No superior vena cava syndrome
- No malignant pericardial effusion
- No near obstruction of the trachea or main stem bronchi
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Total bilirubin < 1.5 times upper limit of normal (ULN) OR
- Direct bilirubin normal
Renal
- Creatinine < 1.5 times ULN
Cardiovascular
- No unstable angina pectoris
- No uncontrolled congestive heart failure
- No myocardial infarction within the past 3 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
participation
- No syndrome of inappropriate antidiuretic hormone secretion
- No ectopic adrenocorticotrophic syndrome
- No Lambert-Eaton myasthenic syndrome
- No other severe paraneoplastic syndrome
- No active infection requiring oral or parenteral antibiotics
- No other life threatening disease
- No other malignancy except basal cell or squamous cell skin cancer, localized
prostate cancer, superficial bladder cancer, or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent filgrastim (G-CSF) during course 1 of study treatment
Chemotherapy
- No more than 1 prior chemotherapy regimen for this malignancy
- Prior cyclophosphamide, doxorubicin, and vincristine (CAV) alternating with
etoposide and cisplatin (EP) allowed
- More than 21 days since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- More than 14 days since prior radiotherapy
- Concurrent palliative radiotherapy allowed except radiotherapy to a solitary measured
index lesion
Surgery
- More than 21 days since prior major surgery
Other
- No other concurrent treatment for this malignancy
- No other concurrent investigational treatment
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response measured by number of responses
Safety Issue:
No
Principal Investigator
James R. Jett, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000415847
NCT ID:
NCT00104754
Start Date:
Completion Date:
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- limited stage small cell lung cancer
- recurrent small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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