Spots Global Cancer Trial Database for Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title: A Phase II Study Of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, To Patients With Progressive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) Following Treatment With Platinum-Based Chemotherapy
Study ID: NCT00061854
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have progressive locally advanced or metastatic non-small cell lung cancer.
Detailed Description: OBJECTIVES: * Determine the objective tumor response rate and duration of response in patients with progressive locally advanced or metastatic non-small cell lung cancer treated with soblidotin as second-line therapy after receiving prior platinum-based chemotherapy. * Determine the time to tumor progression in patients treated with this drug. * Determine the median survival time and 12-month survival rate of patients treated with this drug. * Determine the quantitative and qualitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1. Patients are followed for survival every 3 months after discontinuing study treatment. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical Oncology and Hematology, P.C., Waterbury, Connecticut, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Contact Details
Name: Peter Cheverton, MD, ChB, MMED, RadT
Affiliation: Daiichi Pharmaceuticals
Role: STUDY_CHAIR
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