drugset / Trial / NCT01757288
Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
Phase 1/2
Completed
98 enrolled
University of Texas Southwestern Medical Center
Celgene Corporation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with carboplatin concurrent with daily radiation.
Timeline
- Start
- 2013-03-25
- Primary completion
- 2019-06-03
- Completion
- 2019-06-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nab-paclitaxel | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 50 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | — |