Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00061854|
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : May 16, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: soblidotin||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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 Start Date :||April 2003|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061854
|United States, Connecticut|
|Medical Oncology and Hematology, P.C.|
|Waterbury, Connecticut, United States, 06708|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Peter Cheverton, MD, ChB, MMED, RadT||Daiichi Pharmaceuticals|