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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104754 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: SN-38 liposome |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Previously treated disease
Measurable disease
UGT1A1*28 genotype wt/wt (6/6 promoter TA repeats) OR wt/*28 (6/7 promoter TA repeats)
No uncontrolled CNS metastasis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 1 prior chemotherapy regimen for this malignancy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | James R. Jett, MD | Mayo Clinic |
Investigator: | Marie C. Aubry, MD | Mayo Clinic |
Investigator: | Matthew M. Ames, PhD | Mayo Clinic |
Investigator: | Matthew P. Goetz, MD | Mayo Clinic |
Study ID Numbers: | CDR0000415847, NCCTG-N0322 |
Study First Received: | March 3, 2005 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00104754 |
Health Authority: | United States: Federal Government |
extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Irinotecan Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |