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Sponsored by: |
University of Michigan Cancer Center |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00156286 |
This study involves being treated initially with a combination of drugs called irinotecan and cisplatin (induction therapy), followed by treatment with a drug called Gleevec (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The investigators also want to find out how the tumor is affected solely by induction therapy with irinotecan and cisplatin, what side-effects occur when Gleevec maintenance therapy is used, and if this treatment (induction followed by maintenance therapy) will improve the duration of survival
Condition | Intervention | Phase |
---|---|---|
Small Cell Lung Cancer |
Drug: Gleevec |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Phase II Trial of Gleevec (Imatinib Mesylate, STI571) Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive, Extensive-Stage Small Cell Lung Cancer |
Estimated Enrollment: | 20 |
Study Start Date: | March 2002 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
5. Adequate organ function
6. Patients must sign informed consent that details the investigational nature of the study according to the institutional and federal guidelines.
Exclusion Criteria:
United States, Michigan | |
Univeristy of Michigan Cancer Center | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Gregory Kalemkerian, M.D. | University of Michigan Cancer Center |
Study ID Numbers: | UMCC 2001-066 |
Study First Received: | September 7, 2005 |
Last Updated: | March 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00156286 |
Health Authority: | United States: Institutional Review Board |
Thoracic Neoplasms Carcinoma, Neuroendocrine Irinotecan Carcinoma Neuroendocrine Tumors Imatinib Carcinoma, Small Cell Neuroectodermal Tumors |
Cisplatin 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 Protein Kinase Inhibitors Pharmacologic Actions |