Vanderbilt Clinical Trials

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

Purpose

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.

Condition

STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Eligibility

Eligible Ages: Between 18 Years and 99 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator PACLITAXEL (Phase II, Arm A)	PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY	Drug: PACLITAXEL
Experimental NAB-PACLITAXEL (Phase II, Arm B)	NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks	Drug: NAB-PACLITAXEL nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Other names: Abraxan
Experimental NAB-PACLITAXEL (Phase I)	NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks	Drug: NAB-PACLITAXEL nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Other names: Abraxan

More Details

Status: Completed
Sponsor: University of Texas Southwestern Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.