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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: | NCT00616109 |
The goal of this study is to determine the progression-free survival rate in patients with extensive-stage small cell lung cancer who had achieved complete response, partial response, or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or carboplatin in combination with etoposide or irinotecan. In addition, the safety and effectiveness of sunitinib will also be evaluated.
Condition | Intervention | Phase |
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Extensive-Stage Small Cell Lung Cancer |
Drug: sunitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Phase II Trial of Sunitinib (Sutent, SU11248) Maintenance Therapy After Induction Platinum-Based Chemotherapy in Patients With Extensive-Stage Small Cell Lung Cancer |
Estimated Enrollment: | 39 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: sunitinib
Sunitinib will be given at 50 mg/day as a single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
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Despite a high initial response rate, all patients with extensive-stage SCLC treated with standard chemotherapy will develop disease progression, usually within one year of initial treatment. Therefore, prolonging progression-free survival in this disease is meaningful for clinical trials exploring agents such as sunitinib. Sunitinib is a drug that inhibits the biological pathway responsible for the growth and spread of cancer cells. For this reason, we believe that sunitinib maintenance therapy will delay or prevent recurrence and prolong survival.
The goal of this study is to determine the progression-free survival rate in patients with extensive-stage small cell lung cancer who had achieved complete response, partial response, or stable disease with their previous platinum chemotherapy regimen, such as cisplatin or carboplatin in combination with etoposide or irinotecan. In addition, the safety and effectiveness of sunitinib will also be evaluated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bonnie Reardan, RN | 734.647.6747 | breardan@med.umich.edu |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Bonnie Reardan, RN 734-647-6747 breardan@med.umich.edu | |
Sub-Investigator: Gregory Kalemkerian, MD | |
Sub-Investigator: David Reisman, MD | |
Principal Investigator: Bryan J Schneider, MD |
Principal Investigator: | Bryan J Schneider, MD | University of Michigan Cancer Center |
Responsible Party: | University of Michigan Cancer Center ( Bryan J. Schneider, MD ) |
Study ID Numbers: | UMCC 2007.034, HUM12046 |
Study First Received: | February 4, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00616109 |
Health Authority: | United States: Institutional Review Board |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Sunitinib Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |