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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01757288
Collaborator
Celgene (Industry)
98
5
3
74.3
19.6
0.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Mar 25, 2013
Actual Primary Completion Date :
Jun 3, 2019
Actual Study Completion Date :
Jun 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PACLITAXEL (Phase II, Arm A)

PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY

Drug: PACLITAXEL

Experimental: NAB-PACLITAXEL (Phase II, Arm B)

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

Drug: NAB-PACLITAXEL
nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
Other Names:
  • Abraxan
  • Experimental: NAB-PACLITAXEL (Phase I)

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

    Drug: NAB-PACLITAXEL
    nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
    Other Names:
  • Abraxan
  • Outcome Measures

    Primary Outcome Measures

    1. 2-year Overall Survival (Phase II) [2 years]

      2-year overall survival, as measured (by Kaplan-Meir method) as the percentage of patients who were randomized and received carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy survived for 2 years.

    Secondary Outcome Measures

    1. The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy [60 days of the start of treatment]

      The feasibility as measured by the number of participants who had 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 us defined as the completion of the treatment regimen with no more than minor variations.

    2. Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy [1,6,12,18,24 month]

      The objective response rate (ORR) is defined as the percentage of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria

    3. Proportion of Participants With Progression-free Survival (Phase II) [2 years]

      Proportion of participants with progression free survival at 2 years is computed as the percentage of participants between randomization and local or regional progression, distant metastases, death, or last known follow-up. Estimates of progression free survival will be calculated using the Kaplan-Meir method.

    4. Median Overall Survival (Phase II) [every 6 months up to 24 months (approx. 22 months)]

      Median overall survival was based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.

    5. EuroQol-5Dimension (EQ-5D) MUS Score at Baseline [Baseline]

      EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."

    6. EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment [End of treatment (6 weeks)]

      EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome. Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."

    7. EuroQol-5Dimension (EQ-5D) VAS Score at Baseline [Baseline]

      The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome.

    8. EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment [End of Treatment (6 weeks)]

      The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome.

    9. EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up [24 month follow up]

      The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome.

    10. EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month [24 month follow up]

      EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Rochester New York United States 14642
    2 UPMC Cancer Center Pittsburgh Pennsylvania United States 15232
    3 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    4 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
    5 University of Texas Southwestern Medical Center Dallas Texas United States 75239

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center
    • Celgene

    Investigators

    • Principal Investigator: Yuanyuan Zhang, MD, University of Texas Southwestern Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuanyuan Zhang, Instructor of Department of Radiation Oncology, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT01757288
    Other Study ID Numbers:
    • STU 062012-053
    First Posted:
    Dec 28, 2012
    Last Update Posted:
    Oct 28, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by Yuanyuan Zhang, Instructor of Department of Radiation Oncology, University of Texas Southwestern Medical Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 6 patients enrolled in phase I and 92 patients enrolled in phase II, 46 patints were randomized to Arm A, and 46 patients to Arm B.
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Period Title: Overall Study
    STARTED 6 46 46
    COMPLETED 6 38 37
    NOT COMPLETED 0 8 9

    Baseline Characteristics

    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B) Total
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks NAB-PACLITAXEL: nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy Total of all reporting groups
    Overall Participants 6 46 46 98
    Age, Customized (months,years) [Median (Full Range) ]
    Median age, years
    64
    65.5
    66.5
    66
    Sex: Female, Male (Count of Participants)
    Female
    2
    33.3%
    26
    56.5%
    20
    43.5%
    48
    49%
    Male
    4
    66.7%
    20
    43.5%
    26
    56.5%
    50
    51%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    1
    2.2%
    0
    0%
    1
    1%
    Not Hispanic or Latino
    6
    100%
    45
    97.8%
    45
    97.8%
    96
    98%
    Unknown or Not Reported
    0
    0%
    0
    0%
    1
    2.2%
    1
    1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    1
    2.2%
    1
    1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    2.2%
    0
    0%
    1
    1%
    Black or African American
    0
    0%
    3
    6.5%
    6
    13%
    9
    9.2%
    White
    6
    100%
    41
    89.1%
    38
    82.6%
    85
    86.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    1
    2.2%
    1
    2.2%
    2
    2%

    Outcome Measures

    1. Primary Outcome
    Title 2-year Overall Survival (Phase II)
    Description 2-year overall survival, as measured (by Kaplan-Meir method) as the percentage of patients who were randomized and received carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy survived for 2 years.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    This outcome was collected for Phase II participants only 2- year overall survival.
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks NAB-PACLITAXEL: nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 38 37
    Mean (Full Range) [percentage of participants]
    66.5
    1108.3%
    55.5
    120.7%
    2. Secondary Outcome
    Title The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy
    Description The feasibility as measured by the number of participants who had 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 us defined as the completion of the treatment regimen with no more than minor variations.
    Time Frame 60 days of the start of treatment

    Outcome Measure Data

    Analysis Population Description
    This outcome was collected for Phase I participants only. (6 total).
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 6 0 0
    Count of Participants [Participants]
    0
    0%
    3. Secondary Outcome
    Title Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
    Description The objective response rate (ORR) is defined as the percentage of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria
    Time Frame 1,6,12,18,24 month

    Outcome Measure Data

    Analysis Population Description
    This outcome was measured from Phase II participants only. Percent CR/PR rates by treatment arm.
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 38 37
    1 month scan
    36.8
    613.3%
    45.9
    99.8%
    6 month scan
    21.1
    351.7%
    24.3
    52.8%
    12 month scan
    10.5
    175%
    13.5
    29.3%
    18 month scan
    10.5
    175%
    5.4
    11.7%
    24 month scan
    2.6
    43.3%
    8.1
    17.6%
    4. Secondary Outcome
    Title Proportion of Participants With Progression-free Survival (Phase II)
    Description Proportion of participants with progression free survival at 2 years is computed as the percentage of participants between randomization and local or regional progression, distant metastases, death, or last known follow-up. Estimates of progression free survival will be calculated using the Kaplan-Meir method.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    This outcome was collected from Phase II participants only
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 38 37
    Median (Full Range) [percentage of participants]
    44.4
    740%
    27.3
    59.3%
    5. Secondary Outcome
    Title Median Overall Survival (Phase II)
    Description Median overall survival was based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
    Time Frame every 6 months up to 24 months (approx. 22 months)

    Outcome Measure Data

    Analysis Population Description
    This outcome was measured from Phase II participants only.
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 38 37
    Median (95% Confidence Interval) [months]
    NA
    27.8
    6. Secondary Outcome
    Title EuroQol-5Dimension (EQ-5D) MUS Score at Baseline
    Description EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    This outcome was measure from Phase II participants only
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 38 37
    Median (95% Confidence Interval) [score on a scale]
    0.49
    0.44
    7. Secondary Outcome
    Title EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment
    Description EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome. Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."
    Time Frame End of treatment (6 weeks)

    Outcome Measure Data

    Analysis Population Description
    This outcome was measure from Phase II participants only
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 38 37
    Median (95% Confidence Interval) [score on a scale]
    0.55
    0.45
    8. Secondary Outcome
    Title EuroQol-5Dimension (EQ-5D) VAS Score at Baseline
    Description The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    This outcome was measure from Phase II participants only
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 38 37
    Median (95% Confidence Interval) [score on a scale]
    0.80
    0.79
    9. Secondary Outcome
    Title EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment
    Description The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome.
    Time Frame End of Treatment (6 weeks)

    Outcome Measure Data

    Analysis Population Description
    This outcome was measure from Phase II participants only
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 38 37
    Median (95% Confidence Interval) [score on a scale]
    0.64
    0.78
    10. Secondary Outcome
    Title EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up
    Description The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome.
    Time Frame 24 month follow up

    Outcome Measure Data

    Analysis Population Description
    This outcome measure was only collected for one participant a 24 months due to all other participants not completing the QOL timepoint
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 1 0
    Mean (95% Confidence Interval) [score on a scale]
    0.6
    11. Secondary Outcome
    Title EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month
    Description EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state."
    Time Frame 24 month follow up

    Outcome Measure Data

    Analysis Population Description
    This outcome measure was only collected for one participant a 24 months due t oall other participants not completing the QOL timepoint
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    Measure Participants 0 1 0
    Median (95% Confidence Interval) [score on a scale]
    0.47

    Adverse Events

    Time Frame 4 years
    Adverse Event Reporting Description RECIST criteria
    Arm/Group Title NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Arm/Group Description NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
    All Cause Mortality
    NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 2/38 (5.3%) 3/37 (8.1%)
    Serious Adverse Events
    NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/38 (0%) 0/37 (0%)
    Other (Not Including Serious) Adverse Events
    NAB-PACLITAXEL (Phase I) PACLITAXEL (Phase II, Arm A) NAB-PACLITAXEL (Phase II, Arm B)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 38/38 (100%) 37/37 (100%)
    Blood and lymphatic system disorders
    alanine aminotransferase increased 0/6 (0%) 0 3/38 (7.9%) 3 4/37 (10.8%) 4
    Anemia 0/6 (0%) 0 25/38 (65.8%) 25 26/37 (70.3%) 26
    aspartate aminotransferase increased 0/6 (0%) 0 3/38 (7.9%) 3 3/37 (8.1%) 3
    creatnine elevated 0/6 (0%) 0 4/38 (10.5%) 4 6/37 (16.2%) 6
    dercreased lymphocytes 0/6 (0%) 0 9/38 (23.7%) 9 13/37 (35.1%) 13
    decreased neutrophil count 0/6 (0%) 0 10/38 (26.3%) 10 25/37 (67.6%) 25
    decreased platelet count 0/6 (0%) 0 12/38 (31.6%) 12 19/37 (51.4%) 19
    decreased WBC 0/6 (0%) 0 8/38 (21.1%) 8 20/37 (54.1%) 20
    albumin decreased 0/6 (0%) 0 8/38 (21.1%) 8 12/37 (32.4%) 12
    Alkaline phosphatase increased 0/6 (0%) 0 2/38 (5.3%) 2 4/37 (10.8%) 4
    hyponatremia 0/6 (0%) 0 7/38 (18.4%) 7 10/37 (27%) 10
    thromboembolic event 0/6 (0%) 0 1/38 (2.6%) 1 3/37 (8.1%) 3
    lymphocyte count decreased 0/6 (0%) 0 14/38 (36.8%) 14 22/37 (59.5%) 22
    platelet count decreased 0/6 (0%) 0 12/38 (31.6%) 12 21/37 (56.8%) 21
    neutrophil count decreased 0/6 (0%) 0 9/38 (23.7%) 9 25/37 (67.6%) 25
    BUN elevated 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    Serum amylase increased 0/6 (0%) 0 0/38 (0%) 0 2/37 (5.4%) 2
    Cardiac disorders
    acute respiratory failure 0/6 (0%) 0 1/38 (2.6%) 1 0/37 (0%) 0
    Gastrointestinal disorders
    anorexia 0/6 (0%) 0 10/38 (26.3%) 10 16/37 (43.2%) 16
    constipation 0/6 (0%) 0 5/38 (13.2%) 5 12/37 (32.4%) 12
    diarrhea 0/6 (0%) 0 8/38 (21.1%) 8 6/37 (16.2%) 6
    Abdominal Pain 0/6 (0%) 0 0/38 (0%) 0 4/37 (10.8%) 4
    GERD 0/6 (0%) 0 6/38 (15.8%) 6 8/37 (21.6%) 8
    fecal incontinence 0/6 (0%) 0 1/38 (2.6%) 1 0/37 (0%) 0
    gastritis 0/6 (0%) 0 1/38 (2.6%) 1 1/37 (2.7%) 1
    burning in mouth 0/6 (0%) 0 1/38 (2.6%) 1 0/37 (0%) 0
    anal fungal rash 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    stomatitis 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    Heartburn 0/6 (0%) 0 1/38 (2.6%) 1 0/37 (0%) 0
    throat pain 0/6 (0%) 0 1/38 (2.6%) 1 0/37 (0%) 0
    vomiting 0/6 (0%) 0 9/38 (23.7%) 9 8/37 (21.6%) 8
    General disorders
    arthralgias 0/6 (0%) 0 2/38 (5.3%) 2 2/37 (5.4%) 2
    dehydration 0/6 (0%) 0 6/38 (15.8%) 6 5/37 (13.5%) 5
    dermatitis 0/6 (0%) 0 10/38 (26.3%) 10 10/37 (27%) 10
    dry mouth 0/6 (0%) 0 1/38 (2.6%) 1 2/37 (5.4%) 2
    Fever 0/6 (0%) 0 4/38 (10.5%) 4 9/37 (24.3%) 9
    pleural effusion 0/6 (0%) 0 1/38 (2.6%) 1 2/37 (5.4%) 2
    fatigue 0/6 (0%) 0 19/38 (50%) 19 36/37 (97.3%) 36
    dysphagia 0/6 (0%) 0 16/38 (42.1%) 16 15/37 (40.5%) 15
    dyspnea 0/6 (0%) 0 14/38 (36.8%) 14 19/37 (51.4%) 19
    epistaxis 0/6 (0%) 0 2/38 (5.3%) 2 3/37 (8.1%) 3
    seasonal allergies 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    head congestion 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    chest congestion 0/6 (0%) 0 2/38 (5.3%) 2 1/37 (2.7%) 1
    difficulty swallowing 0/6 (0%) 0 1/38 (2.6%) 1 0/37 (0%) 0
    right clavicular swelling 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    Immune system disorders
    alopecia 0/6 (0%) 0 7/38 (18.4%) 7 9/37 (24.3%) 9
    Infections and infestations
    urinary tract infection 0/6 (0%) 0 0/38 (0%) 0 3/37 (8.1%) 3
    Injury, poisoning and procedural complications
    radiation fibrosis 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    Metabolism and nutrition disorders
    dysgeusia 0/6 (0%) 0 2/38 (5.3%) 2 6/37 (16.2%) 6
    nausea 0/6 (0%) 0 12/38 (31.6%) 12 16/37 (43.2%) 16
    Musculoskeletal and connective tissue disorders
    chest wall pain 0/6 (0%) 0 2/38 (5.3%) 2 2/37 (5.4%) 2
    edema feet 0/6 (0%) 0 2/38 (5.3%) 2 1/37 (2.7%) 1
    gait disturbance 0/6 (0%) 0 1/38 (2.6%) 1 0/37 (0%) 0
    restless leg syndrome 0/6 (0%) 0 1/38 (2.6%) 1 0/37 (0%) 0
    bilateral upper extremity lymphedema 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    abdominal cramping 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    pleuritic pain 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    Nervous system disorders
    dizziness 0/6 (0%) 0 4/38 (10.5%) 4 9/37 (24.3%) 9
    Respiratory, thoracic and mediastinal disorders
    sinusitis 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1
    cough 0/6 (0%) 0 13/38 (34.2%) 13 16/37 (43.2%) 16
    sore throat 0/6 (0%) 0 3/38 (7.9%) 3 5/37 (13.5%) 5
    esophageal stenosis 0/6 (0%) 0 1/38 (2.6%) 1 0/37 (0%) 0
    esophagitis 0/6 (0%) 0 16/38 (42.1%) 16 13/37 (35.1%) 13
    post nasal drip 0/6 (0%) 0 1/38 (2.6%) 1 1/37 (2.7%) 1
    bronchitis 0/6 (0%) 0 1/38 (2.6%) 1 2/37 (5.4%) 2
    Skin and subcutaneous tissue disorders
    dry skin 0/6 (0%) 0 1/38 (2.6%) 1 1/37 (2.7%) 1
    skin irritation 0/6 (0%) 0 0/38 (0%) 0 1/37 (2.7%) 1

    Limitations/Caveats

    For Quality of life endpoints, we were limited by the log questionnaire completion rate. The number of patients completed quality of life questionnaire ranged from 1-8 patients in each are at month 3,6,9,12. Additionally, there was a high rate of missing data for FACT series questionnaire. As a result, we are reporting EQ-5D result at baseline and end of treatment. The responsible party Dr. Hak Choy has been replaced with the Yuanyuan Zhang as Dr. Choy has left UTSouthwestern Medical Center.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Yuanyuan Zhang
    Organization UT Southwestern Medical Center
    Phone 214-648-6764
    Email Yuanyuan.Zhang@UTSouthwestern.edu
    Responsible Party:
    Yuanyuan Zhang, Instructor of Department of Radiation Oncology, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT01757288
    Other Study ID Numbers:
    • STU 062012-053
    First Posted:
    Dec 28, 2012
    Last Update Posted:
    Oct 28, 2021
    Last Verified:
    Oct 1, 2021