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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

Primary Purpose

STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NAB-PACLITAXEL
PACLITAXEL
NAB-PACLITAXEL
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER focused on measuring STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester
  • UPMC Cancer Center
  • Sarah Cannon Research Institute
  • Vanderbilt-Ingram Cancer Center
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

PACLITAXEL (Phase II, Arm A)

NAB-PACLITAXEL (Phase II, Arm B)

NAB-PACLITAXEL (Phase I)

Arm Description

PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY

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

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

Outcomes

Primary Outcome Measures

2-year Overall Survival (Phase II)
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

The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy
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.
Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
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
Proportion of Participants With Progression-free Survival (Phase II)
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.
Median Overall Survival (Phase II)
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.
EuroQol-5Dimension (EQ-5D) MUS Score at 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."
EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment
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."
EuroQol-5Dimension (EQ-5D) VAS Score at 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.
EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment
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.
EuroQol-5Dimension (EQ-5D) VAS Score at 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.
EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month
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."

Full Information

First Posted
December 20, 2012
Last Updated
October 5, 2021
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT01757288
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 25, 2013 (Actual)
Primary Completion Date
June 3, 2019 (Actual)
Study Completion Date
June 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Keywords
STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PACLITAXEL (Phase II, Arm A)
Arm Type
Active Comparator
Arm Description
PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY
Arm Title
NAB-PACLITAXEL (Phase II, Arm B)
Arm Type
Experimental
Arm Description
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
Arm Title
NAB-PACLITAXEL (Phase I)
Arm Type
Experimental
Arm Description
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
Intervention Type
Drug
Intervention Name(s)
NAB-PACLITAXEL
Other Intervention Name(s)
Abraxan
Intervention Description
nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
Intervention Type
Drug
Intervention Name(s)
PACLITAXEL
Intervention Type
Drug
Intervention Name(s)
NAB-PACLITAXEL
Other Intervention Name(s)
Abraxan
Intervention Description
nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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)
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
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)
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
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)
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanyuan Zhang, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75239
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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