Liposomal SN-38 in Treating Patients With Small Cell Lung Cancer
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First Received Date ICMJE | March 3, 2005 | ||||||||||||||||
Last Updated Date | January 22, 2011 | ||||||||||||||||
Start Date ICMJE | |||||||||||||||||
Primary Completion Date | |||||||||||||||||
Current Primary Outcome Measures ICMJE |
Tumor response measured by number of responses [ Designated as safety issue: No ] | ||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | Complete list of historical versions of study NCT00104754 on ClinicalTrials.gov Archive Site | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Liposomal SN-38 in Treating Patients With Small Cell Lung Cancer | ||||||||||||||||
Official Title ICMJE | Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer | ||||||||||||||||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with small cell lung cancer. |
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Detailed Description | OBJECTIVES:
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase | Phase 2 | ||||||||||||||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Lung Cancer | ||||||||||||||||
Intervention ICMJE | Drug: liposomal SN-38 | ||||||||||||||||
Study Arm (s) | |||||||||||||||||
Publications * | |||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Suspended | ||||||||||||||||
Enrollment ICMJE | |||||||||||||||||
Completion Date | |||||||||||||||||
Primary Completion Date | |||||||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||||||||||||||
Ages | 18 Years and older | ||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Location Countries ICMJE | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT00104754 | ||||||||||||||||
Other Study ID Numbers ICMJE | CDR0000415847, NCCTG-N0322 | ||||||||||||||||
Has Data Monitoring Committee | |||||||||||||||||
Responsible Party | Charles L. Loprinzi, Mayo Clinic Cancer Center | ||||||||||||||||
Study Sponsor ICMJE | North Central Cancer Treatment Group | ||||||||||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||
Verification Date | January 2009 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |