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 |
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.
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
sites
2220 Pierce Ave
Nashville, Tennessee 37232
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
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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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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3322 West End Avenue
Nashville, Tennessee 37203
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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