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Recruitment Status : Withdrawn
First Posted : December 19, 2007
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|NSCLC||Drug: CT-2103/carboplatin Drug: paclitaxel/carboplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 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|
|Actual Study Start Date :||September 2007|
|Actual Primary Completion Date :||April 5, 2010|
|Actual Study Completion Date :||April 5, 2010|
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|