Clinical Research Details
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
Purpose:
The investigational drug for this study is paclitaxel poliglumex (CT-2103). CT-2103 is a chemotherapeutic agent that links paclitaxel (chemotherapy agent) to amino acids. Once CT-2103 is inside a cell, proteins in the cell break down CT-2103 releasing paclitaxel.
Study Number:
200385
Number of Patients:
450
Elgibility:
Participant must be a woman with baseline estradiol >25 pg/mL with NSCLC Stage IIIB, IV or recurrent cancer. Participant must be chemo naïve and have an ECOG performance status of 0, 1 or 2.
Treatment:
The study consists of three phases: the initial evaluation phase, the treatment phase and the follow-up phase. During the evaluation phase, you will have some testing to see whether you can receive the treatments in this study. If the tests show that you qualify to participate in the research, you will be assigned by lottery to receive treatment with either the investigational drug CT-2103 with carboplatin, or paclitaxel with carboplatin. During the treatment phase, you will receive treatment every three weeks. This three-week period is called a cycle of treatment. You may receive up to 6 cycles of treatment.
Principal Investigator:
Enrollment Phone:
(708) 327-3229