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

NCT ID: NCT01757288

Last Updated: 2021-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-25

Study Completion Date

2019-06-03

Brief Summary

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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.

Detailed Description

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Conditions

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STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Keywords

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STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PACLITAXEL (Phase II, Arm A)

PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY

Group Type ACTIVE_COMPARATOR

PACLITAXEL

Intervention Type DRUG

NAB-PACLITAXEL (Phase II, Arm B)

NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks

Group Type EXPERIMENTAL

NAB-PACLITAXEL

Intervention Type DRUG

nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks

NAB-PACLITAXEL (Phase I)

NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks

Group Type EXPERIMENTAL

NAB-PACLITAXEL

Intervention Type DRUG

nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks

Interventions

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NAB-PACLITAXEL

nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks

Intervention Type DRUG

PACLITAXEL

Intervention Type DRUG

NAB-PACLITAXEL

nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks

Intervention Type DRUG

Other Intervention Names

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Abraxan Abraxan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yuanyuan Zhang

Instructor of Department of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuanyuan Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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University of Rochester

Rochester, New York, United States

Site Status

UPMC Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STU 062012-053

Identifier Type: -

Identifier Source: org_study_id