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



Status:Active, not recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/10/2019
Start Date:March 25, 2013
End Date:February 2021

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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)

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.


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
We found this trial at
5
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Phone: 877-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Phone: 585-275-2171
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Phone: 877-691-7274
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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Pittsburgh, Pennsylvania 15232
Phone: 877-470-7241
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Pittsburgh, PA
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