A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy. - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	December 22, 2005
Last Updated Date	February 13, 2007
Start Date ^†	December 2005
Current Primary Outcome Measures ^† (submitted: December 23, 2005)	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 ^† (submitted: December 23, 2005)	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 ^†	Drug: paclitaxel Drug: paclitaxel poliglumex
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.

Recruitment Information
Recruitment Status ^†	Terminated
Enrollment ^†	600
Completion Date	December 2006
Primary Completion Date
Eligibility Criteria ^†	Inclusion Criteria: Female. Histologically- or cytologically-confirmed diagnosis of NSCLC. ECOG performance score of 2. Patients who meet one of the following criteria: Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or Stage IV. Age greater than or equal to 18 years. Adequate bone marrow function Adequate renal function Adequate hepatic function Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site’s institutional standards. Patients who have had major surgery must be fully recovered from the surgery. Ability to comply with the visit schedule and assessments required by the protocol. For patients of reproductive potential, commitment to use adequate contraception. Signed approved informed consent, with understanding of study procedures. Agreement to begin study therapy within 8 calendar days after randomization. Exclusion Criteria: Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103). Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. Grade 2 or greater neuropathy. Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. (If unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9). Clinically significant active infection for which active therapy is underway. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable. Pregnant women or nursing mothers. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
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.