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Tracking Information | |
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First Received Date † | December 22, 2005 |
Last Updated Date | February 13, 2007 |
Start Date † | December 2005 |
Current Primary Outcome Measures † |
The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel. |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00269828 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
Secondary objectives are to compare the progression-free survival, response rate, disease control, clinical benefit, quality of life, and the safety and tolerability of the treatment arms. |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy. |
Official Title † | Paclitaxel Poliglumex (CT-2103) vs. Paclitaxel for the Treatment of Women With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) Who Are Performance Status 2. |
Brief Summary | This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2. Study drug will be administered on day 1 of each 21 day cycle |
Detailed Description | See Summary |
Study Phase | Phase III |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Condition † | NSCLC |
Intervention † |
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Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Terminated |
Enrollment † | 600 |
Completion Date | December 2006 |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States, Argentina, Bulgaria, Canada, Hungary, Mexico, Poland, Romania, Russian Federation, Ukraine, United Kingdom |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00269828 |
Responsible Party | |
Secondary IDs †† | PIONEER |
Study Sponsor † | Cell Therapeutics |
Collaborators †† | |
Investigators † | |
Information Provided By | Cell Therapeutics |
Verification Date | February 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |