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Sponsored by: |
Istituto Clinico Humanitas |
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Information provided by: | Istituto Clinico Humanitas |
ClinicalTrials.gov Identifier: | NCT00697476 |
The purpose of this study is to evaluate the maximum tolerated dose, the activity and the safety profile of the combination of vorinostat and topotecan in patients with recurrent small cell lung cancer
Condition | Intervention | Phase |
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Small Cell Lung Cancer |
Drug: topotecan, vorinostat |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I-II Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With Topotecan in Patients With Chemosensitive Recurrent Small Cell Lung Cancer (SCLC) |
Estimated Enrollment: | 78 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Phase I study: vorinostat will be administered daily for a number of days per cycle variable from 7 to 14 according to the level of dose escalation; topotecan will be administered I.V. for 5 consecutive days every 3 weeks. Three patients will be entered at each dose level. If none of the first 3 patients at a dose level experiences a DLT after 1 cycle (21 days) then 3 new patients may be entered at the next higher dose level. If 1 of 3 patients experiences a DLT, up to 3 more patients are started at that same dose level (total n=6). If 2 or more experience a DLT, no further patients are started at that dose. The MTD is one dose level below dose at which ³ 2 patients experience DLT.
Phase II study: Patients will receive treatment at the recommended dose established by phase I part of the trial, for a maximum of 6 cycles or until disease progression, unacceptable toxicity or patient's refusal.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Istituto Clinico Humanitas ( Armando Santoro, MD ) |
Study ID Numbers: | ONC-2007-002, EUDRACT |
Study First Received: | June 11, 2008 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00697476 History of Changes |
Health Authority: | Italy: Ministry of Health |
second line chemotherapy |
Anticarcinogenic Agents Anti-Inflammatory Agents Disulfiram Thoracic Neoplasms Carcinoma, Neuroendocrine Vorinostat Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Analgesics, Non-Narcotic Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Topotecan Adenocarcinoma Neoplasms, Glandular and Epithelial |
Anticarcinogenic Agents Anti-Inflammatory Agents Thoracic Neoplasms Carcinoma, Neuroendocrine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Neoplasms by Site Respiratory Tract Diseases Sensory System Agents Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Respiratory Tract Neoplasms Neoplasms by Histologic Type Vorinostat Enzyme Inhibitors Protective Agents Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Analgesics, Non-Narcotic Lung Diseases Peripheral Nervous System Agents |