Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B 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 carboplatin concurrent with daily radiation.
Checked against the public recordLast updated Oct 28, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- University of Texas Southwestern Medical Center
- Interventions being studied
- Drug: NAB-PACLITAXEL; Drug: PACLITAXEL; Drug: NAB-PACLITAXEL
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of RochesterRochester, New York
- UPMC Cancer CenterPittsburgh, Pennsylvania
- Sarah Cannon Research InstituteNashville, Tennessee
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee
- University of Texas Southwestern Medical CenterDallas, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 28, 2021. Always confirm current availability with the study team.