CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
NAB-PACLITAXEL +2 moredrug
Likely dose
NAB-PACLITAXEL 50 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01757288
NCT01757288Phase 2Completed
CompareCT.gov

A RANDOMIZED PHASE I/II STUDY OF NAB-PACLITAXEL, OR PACLITAXEL, PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY FOLLoWED BY CONSOLIDATION IN PATIENTS WITH FAVORABLE PROGNOSIS INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)

University of Texas Southwestern Medical Center·interventional·Posted Dec 28, 2012·Updated Oct 28, 2021

In Brief

A Phase 2 clinical trial evaluating NAB-PACLITAXEL and PACLITAXEL for STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER. Completed, enrolled 98 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSTAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 28, 2012
Enrollment StartMar 25, 2013
Primary CompletionJun 3, 2019
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 13.5 years ago

Interventions

NAB-PACLITAXELdrug

nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks

PACLITAXELdrug

NAB-PACLITAXELdrug

nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks