CT-2103/Carboplatin vs Paclitaxel/Carboplatin for NSCLC in Women With Estradiol > 25 pg/mL
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|ClinicalTrials.gov Identifier: NCT00576225|
Recruitment Status : Unknown
Verified May 2013 by CTI BioPharma.
Recruitment status was: Active, not recruiting
First Posted : December 19, 2007
Last Update Posted : May 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|NSCLC||Drug: CT-2103/carboplatin Drug: paclitaxel/carboplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women With Estradiol > 25 pg/mL|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
CT-2103 (175 mg/m2 10 min IV infusion) and carboplatin (AUC 6, 30 min IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
|Active Comparator: Control||
Paclitaxel (175 mg/m2, 3 hr IV infusion) and carboplatin (AUC 6) (30 minute IV infusion) on day 1 of each 21-day cycle for up to 6 cycles.
- Survival [ Time Frame: up to 3 years post treatment ]
- progression-free survival, disease control, clinical benefit, response rate, quality of life, and the safety [ Time Frame: up to 3 years post treatment ]
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): NCT00576225
|Study Director:||Jack W. Singer, M.D.||CTI BioPharma|