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

Study Overview
=================
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

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.

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: paclitaxel
* Drug: paclitaxel poliglumex


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paclitaxel|nan|
|Drug: paclitaxel poliglumex|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer, NSCLC, PS 2, female, chemotherapy