Clinical Trials /

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

NCT01757288

Description:

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 with carboplatin concurrent with daily radiation.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
  • Official Title: A RANDOMIZED PHASE I/II STUDY OF NAB-PACLITAXEL, OR PACLITAXEL, PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY FOLLoWED BY CONSOLIDATION IN PATIENTS WITH FAVORABLE PROGNOSIS INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: STU 062012-053
  • NCT ID: NCT01757288

Conditions

  • STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Interventions

DrugSynonymsArms
NAB-PACLITAXELAbraxanNAB-PACLITAXEL
PACLITAXELPACLITAXEL

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 with carboplatin concurrent with daily radiation.

Trial Arms

NameTypeDescriptionInterventions
PACLITAXELActive ComparatorPACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY
  • PACLITAXEL
NAB-PACLITAXELExperimentalNAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY
  • NAB-PACLITAXEL

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
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:2-year overall survival from randomization for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:the feasibility of concurrent carboplatin/nab-paclitaxel and radiation therapy
Time Frame:60 days of the start of treatment
Safety Issue:
Description:Safety is measured by the rate of grade 3 or higher radiation related esophagitis or pulmonary toxicity or chemotherapy related grade 4 hematological or other non-hematological toxicities occurring within 60 days of the start of treatment; compliance is defined as the completion of the treatment regimen with no more than minor variations.
Measure:overall response rate for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy
Time Frame:4 years
Safety Issue:
Description:
Measure:the progression-free survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy
Time Frame:4 years
Safety Issue:
Description:
Measure:the median overall survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy
Time Frame:4 years
Safety Issue:
Description:
Measure:quality of life (QOL) of patients receiving either nab-paclitaxel or paclitaxel when given with concurrent radiotherapy
Time Frame:4 years
Safety Issue:
Description:
Measure:correlate outcomes (survival, toxicity, QOL) with biological parameters
Time Frame:4 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Texas Southwestern Medical Center

Trial Keywords

  • STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Last Updated

July 14, 2016