Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC

Study ID
STU 062012-053

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • UT Southwestern Moncrieff Cancer Center
  • Zale Lipshy University Hospital
  • Parkland Health & Hospital System

Contact
Shahbano Shakeel
214/729-2644
shahbano.shakeel@utsouthwestern.edu

Principal Investigator
Hak Choy, M.D.

Official Title

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)

Brief Overview


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 with carboplatin concurrent with daily radiation.

Participant Eligibility


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 < 50% of the ipsilateral lung volume.

- Patients with Zubrod performance status 0-1

- Adequate hematologic function

- FEV1 with ≥ 1200 cc or ≥ 50% predicted

Exclusion Criteria:

- Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for
any reason and/or surgical resection of present cancer

- Exudative, bloody, or cytologically malignant effusions

- Prior therapy with any molecular targeted drugs (for lung cancer)

- Active pulmonary infection not responsive to conventional antibiotics

- Clinically significant cardiovascular event (e.g. myocardial infarction, superior
vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart
disease >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