Phase 2
N=98
Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Bottom Line
View on ClinicalTrials.gov: NCT01757288 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: 2-year Overall Survival (Phase II) — 66.5; 55.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NAB-PACLITAXEL (Drug); PACLITAXEL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-year Overall Survival (Phase II) |
66.5; 55.5 | — |
| SECONDARY The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy |
— | — |
| SECONDARY Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy |
36.8; 45.9; 21.1; 24.3; 10.5; 13.5 | — |
| SECONDARY Proportion of Participants With Progression-free Survival (Phase II) |
44.4; 27.3 | — |
| SECONDARY Median Overall Survival (Phase II) |
NA; 27.8 | — |
| SECONDARY EuroQol-5Dimension (EQ-5D) MUS Score at Baseline |
0.49; 0.44 | — |
| SECONDARY EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment |
0.55; 0.45 | — |
| SECONDARY EuroQol-5Dimension (EQ-5D) VAS Score at Baseline |
0.80; 0.79 | — |
| SECONDARY EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment |
0.64; 0.78 | — |
| SECONDARY EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up |
0.6 | — |
| SECONDARY EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month |
0.47 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically documented NSCLC; Patients must be M0. Patients with T1-T2 with N2 or T3N1-2 are eligible, if inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable.
- Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to 2 (see Appendix B) within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
- Patients with > grade 1 neuropathy
Data sourced from ClinicalTrials.gov (NCT01757288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.