CompletedPhase 1 / Phase 2NCT01757288

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

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations5
SponsorUniversity of Texas Southwestern Medical Center
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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