Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

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 < 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 is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

98

Study ID:

NCT01757288

Recruitment Status:

Completed

Sponsor:

University of Texas Southwestern Medical Center

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There are 5 Locations for this study

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University of Rochester
Rochester New York, 14642, United States
UPMC Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75239, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

98

Study ID:

NCT01757288

Recruitment Status:

Completed

Sponsor:


University of Texas Southwestern Medical Center

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