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Sponsors and Collaborators: |
University of Alabama at Birmingham National Comprehensive Cancer Network |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00856830 |
SCLC constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States(1). Extensive-Stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 months(2). SCLC is one of the most aggressive and lethal types of cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with extensive disease(3). Overall, the majority of patients with SCLC die in less than 2 years (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for patients with extensive disease(4). The regimen of etoposide in combination with a platinum (cisplatin or carboplatin) is generally considered the "standard of care" although a recent Phase III trial suggests improved survival with the combination of cisplatin/irinotecan(5). Further evaluation of new agents in combination regimens attempting to overcome the intrinsic drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and achieve palliation of disease-related symptoms.
Condition | Intervention | Phase |
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Small Cell Lung Cancer Chemonaive Extensive Stage |
Drug: Bendamustine, Irinotecan, Etoposide/Carboplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/IIa Study of the Novel Combination of Bendamustine With Irinotecan Followed by Etoposide/Carboplatin in Chemonaive Patients With Extensive Stage Small Cell Lung Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Subjects will be treated with irinotecan (150 mg/m2) infusion on Day 1 followed by infusion of bendamustine on Days 1 and 2 at increasing dose levels using a 3+3 design (starting dose of 80-mg/m2/d with 20 mg/mg/d incremental increase to max 120 mg/m2/d) (Regimen A). This will be repeated every 3 weeks for a total of 3 cycles. Restaging for response will be performed prior to the next regimen.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anna Messer, RN, OCN | (205) 934-5092 | Anna.Messer@ccc.uab.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 - 0104 | |
Principal Investigator: Francisco Robert, M.D. |
Principal Investigator: | Francisco Robert, M.D. | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( Francisco Robert, M.D. ) |
Study ID Numbers: | F080929010, UAB 0818 |
Study First Received: | March 5, 2009 |
Last Updated: | August 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00856830 History of Changes |
Health Authority: | United States: Institutional Review Board |
Thoracic Neoplasms Carcinoma, Neuroendocrine Irinotecan Carboplatin Etoposide phosphate Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Antineoplastic Agents, Phytogenic Etoposide Bendamustine Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Irinotecan Etoposide phosphate Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Etoposide Bendamustine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Carboplatin Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Lung Diseases Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |