Trial Outcomes & Findings for Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC (NCT NCT01757288)
NCT ID: NCT01757288
Last Updated: 2021-10-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
98 participants
Primary outcome timeframe
2 years
Results posted on
2021-10-28
Participant Flow
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.
Participant milestones
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
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 (Phase II, Arm B)
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
46
|
46
|
|
Overall Study
COMPLETED
|
6
|
38
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
8
|
9
|
Reasons for withdrawal
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
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 (Phase II, Arm B)
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
|
|---|---|---|---|
|
Overall Study
Consent withdrawal
|
0
|
4
|
4
|
|
Overall Study
Patient off study, IRB hold.
|
0
|
0
|
1
|
|
Overall Study
Patient death prior to starting treatment
|
0
|
0
|
1
|
|
Overall Study
Wrong medication administered
|
0
|
1
|
0
|
|
Overall Study
Liver metastasis identified at CT simulation
|
0
|
1
|
0
|
|
Overall Study
Not meeting protocol constraints
|
0
|
1
|
1
|
|
Overall Study
Multiple missed appointments
|
0
|
1
|
0
|
|
Overall Study
Mulitple hospitalization ( after first week of CRT)
|
0
|
0
|
1
|
|
Overall Study
>2 weeks treatment break
|
0
|
0
|
1
|
Baseline Characteristics
Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
Baseline characteristics by cohort
| Measure |
NAB-PACLITAXEL (Phase I)
n=6 Participants
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 (Phase II, Arm A)
n=46 Participants
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 (Phase II, Arm B)
n=46 Participants
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
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Median age, years
|
64 months,years
n=5 Participants
|
65.5 months,years
n=7 Participants
|
66.5 months,years
n=5 Participants
|
66 months,years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: This outcome was collected for Phase II participants only 2- year overall survival.
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.
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=38 Participants
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 (Phase II, Arm B)
n=37 Participants
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
|
|---|---|---|---|
|
2-year Overall Survival (Phase II)
|
—
|
66.5 percentage of participants
Interval 48.4 to 79.5
|
55.5 percentage of participants
Interval 36.3 to 71.0
|
SECONDARY outcome
Timeframe: 60 days of the start of treatmentPopulation: This outcome was collected for Phase I participants only. (6 total).
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.
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
n=6 Participants
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 (Phase II, Arm A)
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 (Phase II, Arm B)
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
|
|---|---|---|---|
|
The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1,6,12,18,24 monthPopulation: This outcome was measured from Phase II participants only. Percent CR/PR rates by treatment arm.
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
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=38 Participants
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 (Phase II, Arm B)
n=37 Participants
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
|
|---|---|---|---|
|
Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
1 month scan
|
—
|
36.8 percentage of participants
Interval 21.8 to 54.0
|
45.9 percentage of participants
Interval 29.5 to 63.1
|
|
Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
6 month scan
|
—
|
21.1 percentage of participants
Interval 9.6 to 37.3
|
24.3 percentage of participants
Interval 11.8 to 41.2
|
|
Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
12 month scan
|
—
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
13.5 percentage of participants
Interval 4.5 to 28.8
|
|
Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
18 month scan
|
—
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
|
Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
24 month scan
|
—
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: This outcome was collected from Phase II participants only
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.
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=38 Participants
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 (Phase II, Arm B)
n=37 Participants
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
|
|---|---|---|---|
|
Proportion of Participants With Progression-free Survival (Phase II)
|
—
|
44.4 percentage of participants
Interval 27.6 to 59.9
|
27.3 percentage of participants
Interval 13.7 to 42.9
|
SECONDARY outcome
Timeframe: every 6 months up to 24 months (approx. 22 months)Population: This outcome was measured from Phase II participants only.
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.
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=38 Participants
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 (Phase II, Arm B)
n=37 Participants
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
|
|---|---|---|---|
|
Median Overall Survival (Phase II)
|
—
|
NA months
Interval 0.0 to 0.0
Median survival rate not reached by any of the participants enrolled in this arm
|
27.8 months
Interval 16.8 to 37.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: This outcome was measure from Phase II participants only
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."
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=38 Participants
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 (Phase II, Arm B)
n=37 Participants
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
|
|---|---|---|---|
|
EuroQol-5Dimension (EQ-5D) MUS Score at Baseline
|
—
|
0.49 score on a scale
Interval 0.4 to 0.57
|
0.44 score on a scale
Interval 0.39 to 0.5
|
SECONDARY outcome
Timeframe: End of treatment (6 weeks)Population: This outcome was measure from Phase II participants only
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."
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=38 Participants
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 (Phase II, Arm B)
n=37 Participants
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
|
|---|---|---|---|
|
EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment
|
—
|
0.55 score on a scale
Interval 0.44 to 0.67
|
0.45 score on a scale
Interval 0.39 to 0.52
|
SECONDARY outcome
Timeframe: BaselinePopulation: This outcome was measure from Phase II participants only
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.
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=38 Participants
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 (Phase II, Arm B)
n=37 Participants
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
|
|---|---|---|---|
|
EuroQol-5Dimension (EQ-5D) VAS Score at Baseline
|
—
|
0.80 score on a scale
Interval 0.72 to 0.88
|
0.79 score on a scale
Interval 0.72 to 0.87
|
SECONDARY outcome
Timeframe: End of Treatment (6 weeks)Population: This outcome was measure from Phase II participants only
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.
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=38 Participants
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 (Phase II, Arm B)
n=37 Participants
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
|
|---|---|---|---|
|
EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment
|
—
|
0.64 score on a scale
Interval 0.5 to 0.79
|
0.78 score on a scale
Interval 0.71 to 0.86
|
SECONDARY outcome
Timeframe: 24 month follow upPopulation: This outcome measure was only collected for one participant a 24 months due to all other participants not completing the QOL timepoint
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.
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=1 Participants
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 (Phase II, Arm B)
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
|
|---|---|---|---|
|
EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up
|
—
|
0.6 score on a scale
Interval 0.6 to 0.6
|
—
|
SECONDARY outcome
Timeframe: 24 month follow upPopulation: This outcome measure was only collected for one participant a 24 months due t oall other participants not completing the QOL timepoint
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."
Outcome measures
| Measure |
NAB-PACLITAXEL (Phase I)
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 (Phase II, Arm A)
n=1 Participants
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 (Phase II, Arm B)
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
|
|---|---|---|---|
|
EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month
|
—
|
0.47 score on a scale
Interval 0.47 to 0.47
|
—
|
Adverse Events
NAB-PACLITAXEL (Phase I)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PACLITAXEL (Phase II, Arm A)
Serious events: 0 serious events
Other events: 38 other events
Deaths: 2 deaths
NAB-PACLITAXEL (Phase II, Arm B)
Serious events: 0 serious events
Other events: 37 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NAB-PACLITAXEL (Phase I)
n=6 participants at risk
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 (Phase II, Arm A)
n=38 participants at risk
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 (Phase II, Arm B)
n=37 participants at risk
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
|
|---|---|---|---|
|
Cardiac disorders
acute respiratory failure
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
0.00%
0/37 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
alanine aminotransferase increased
|
0.00%
0/6 • 4 years
RECIST criteria
|
7.9%
3/38 • Number of events 3 • 4 years
RECIST criteria
|
10.8%
4/37 • Number of events 4 • 4 years
RECIST criteria
|
|
Immune system disorders
alopecia
|
0.00%
0/6 • 4 years
RECIST criteria
|
18.4%
7/38 • Number of events 7 • 4 years
RECIST criteria
|
24.3%
9/37 • Number of events 9 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • 4 years
RECIST criteria
|
65.8%
25/38 • Number of events 25 • 4 years
RECIST criteria
|
70.3%
26/37 • Number of events 26 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
anorexia
|
0.00%
0/6 • 4 years
RECIST criteria
|
26.3%
10/38 • Number of events 10 • 4 years
RECIST criteria
|
43.2%
16/37 • Number of events 16 • 4 years
RECIST criteria
|
|
General disorders
arthralgias
|
0.00%
0/6 • 4 years
RECIST criteria
|
5.3%
2/38 • Number of events 2 • 4 years
RECIST criteria
|
5.4%
2/37 • Number of events 2 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
aspartate aminotransferase increased
|
0.00%
0/6 • 4 years
RECIST criteria
|
7.9%
3/38 • Number of events 3 • 4 years
RECIST criteria
|
8.1%
3/37 • Number of events 3 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/6 • 4 years
RECIST criteria
|
13.2%
5/38 • Number of events 5 • 4 years
RECIST criteria
|
32.4%
12/37 • Number of events 12 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
creatnine elevated
|
0.00%
0/6 • 4 years
RECIST criteria
|
10.5%
4/38 • Number of events 4 • 4 years
RECIST criteria
|
16.2%
6/37 • Number of events 6 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
dercreased lymphocytes
|
0.00%
0/6 • 4 years
RECIST criteria
|
23.7%
9/38 • Number of events 9 • 4 years
RECIST criteria
|
35.1%
13/37 • Number of events 13 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
decreased neutrophil count
|
0.00%
0/6 • 4 years
RECIST criteria
|
26.3%
10/38 • Number of events 10 • 4 years
RECIST criteria
|
67.6%
25/37 • Number of events 25 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
decreased platelet count
|
0.00%
0/6 • 4 years
RECIST criteria
|
31.6%
12/38 • Number of events 12 • 4 years
RECIST criteria
|
51.4%
19/37 • Number of events 19 • 4 years
RECIST criteria
|
|
General disorders
dehydration
|
0.00%
0/6 • 4 years
RECIST criteria
|
15.8%
6/38 • Number of events 6 • 4 years
RECIST criteria
|
13.5%
5/37 • Number of events 5 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
decreased WBC
|
0.00%
0/6 • 4 years
RECIST criteria
|
21.1%
8/38 • Number of events 8 • 4 years
RECIST criteria
|
54.1%
20/37 • Number of events 20 • 4 years
RECIST criteria
|
|
General disorders
dermatitis
|
0.00%
0/6 • 4 years
RECIST criteria
|
26.3%
10/38 • Number of events 10 • 4 years
RECIST criteria
|
27.0%
10/37 • Number of events 10 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/6 • 4 years
RECIST criteria
|
21.1%
8/38 • Number of events 8 • 4 years
RECIST criteria
|
16.2%
6/37 • Number of events 6 • 4 years
RECIST criteria
|
|
General disorders
dry mouth
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
5.4%
2/37 • Number of events 2 • 4 years
RECIST criteria
|
|
Metabolism and nutrition disorders
dysgeusia
|
0.00%
0/6 • 4 years
RECIST criteria
|
5.3%
2/38 • Number of events 2 • 4 years
RECIST criteria
|
16.2%
6/37 • Number of events 6 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
10.8%
4/37 • Number of events 4 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
albumin decreased
|
0.00%
0/6 • 4 years
RECIST criteria
|
21.1%
8/38 • Number of events 8 • 4 years
RECIST criteria
|
32.4%
12/37 • Number of events 12 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
0.00%
0/6 • 4 years
RECIST criteria
|
5.3%
2/38 • Number of events 2 • 4 years
RECIST criteria
|
10.8%
4/37 • Number of events 4 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
hyponatremia
|
0.00%
0/6 • 4 years
RECIST criteria
|
18.4%
7/38 • Number of events 7 • 4 years
RECIST criteria
|
27.0%
10/37 • Number of events 10 • 4 years
RECIST criteria
|
|
Respiratory, thoracic and mediastinal disorders
sinusitis
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
thromboembolic event
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
8.1%
3/37 • Number of events 3 • 4 years
RECIST criteria
|
|
General disorders
Fever
|
0.00%
0/6 • 4 years
RECIST criteria
|
10.5%
4/38 • Number of events 4 • 4 years
RECIST criteria
|
24.3%
9/37 • Number of events 9 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
0.00%
0/6 • 4 years
RECIST criteria
|
36.8%
14/38 • Number of events 14 • 4 years
RECIST criteria
|
59.5%
22/37 • Number of events 22 • 4 years
RECIST criteria
|
|
Musculoskeletal and connective tissue disorders
chest wall pain
|
0.00%
0/6 • 4 years
RECIST criteria
|
5.3%
2/38 • Number of events 2 • 4 years
RECIST criteria
|
5.4%
2/37 • Number of events 2 • 4 years
RECIST criteria
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/6 • 4 years
RECIST criteria
|
34.2%
13/38 • Number of events 13 • 4 years
RECIST criteria
|
43.2%
16/37 • Number of events 16 • 4 years
RECIST criteria
|
|
General disorders
pleural effusion
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
5.4%
2/37 • Number of events 2 • 4 years
RECIST criteria
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/6 • 4 years
RECIST criteria
|
7.9%
3/38 • Number of events 3 • 4 years
RECIST criteria
|
13.5%
5/37 • Number of events 5 • 4 years
RECIST criteria
|
|
General disorders
fatigue
|
0.00%
0/6 • 4 years
RECIST criteria
|
50.0%
19/38 • Number of events 19 • 4 years
RECIST criteria
|
97.3%
36/37 • Number of events 36 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
platelet count decreased
|
0.00%
0/6 • 4 years
RECIST criteria
|
31.6%
12/38 • Number of events 12 • 4 years
RECIST criteria
|
56.8%
21/37 • Number of events 21 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/6 • 4 years
RECIST criteria
|
15.8%
6/38 • Number of events 6 • 4 years
RECIST criteria
|
21.6%
8/37 • Number of events 8 • 4 years
RECIST criteria
|
|
Metabolism and nutrition disorders
nausea
|
0.00%
0/6 • 4 years
RECIST criteria
|
31.6%
12/38 • Number of events 12 • 4 years
RECIST criteria
|
43.2%
16/37 • Number of events 16 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
0.00%
0/6 • 4 years
RECIST criteria
|
23.7%
9/38 • Number of events 9 • 4 years
RECIST criteria
|
67.6%
25/37 • Number of events 25 • 4 years
RECIST criteria
|
|
Nervous system disorders
dizziness
|
0.00%
0/6 • 4 years
RECIST criteria
|
10.5%
4/38 • Number of events 4 • 4 years
RECIST criteria
|
24.3%
9/37 • Number of events 9 • 4 years
RECIST criteria
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
General disorders
dysphagia
|
0.00%
0/6 • 4 years
RECIST criteria
|
42.1%
16/38 • Number of events 16 • 4 years
RECIST criteria
|
40.5%
15/37 • Number of events 15 • 4 years
RECIST criteria
|
|
General disorders
dyspnea
|
0.00%
0/6 • 4 years
RECIST criteria
|
36.8%
14/38 • Number of events 14 • 4 years
RECIST criteria
|
51.4%
19/37 • Number of events 19 • 4 years
RECIST criteria
|
|
Musculoskeletal and connective tissue disorders
edema feet
|
0.00%
0/6 • 4 years
RECIST criteria
|
5.3%
2/38 • Number of events 2 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
General disorders
epistaxis
|
0.00%
0/6 • 4 years
RECIST criteria
|
5.3%
2/38 • Number of events 2 • 4 years
RECIST criteria
|
8.1%
3/37 • Number of events 3 • 4 years
RECIST criteria
|
|
Respiratory, thoracic and mediastinal disorders
esophageal stenosis
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
0.00%
0/37 • 4 years
RECIST criteria
|
|
Respiratory, thoracic and mediastinal disorders
esophagitis
|
0.00%
0/6 • 4 years
RECIST criteria
|
42.1%
16/38 • Number of events 16 • 4 years
RECIST criteria
|
35.1%
13/37 • Number of events 13 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
fecal incontinence
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
0.00%
0/37 • 4 years
RECIST criteria
|
|
Musculoskeletal and connective tissue disorders
gait disturbance
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
0.00%
0/37 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
gastritis
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
burning in mouth
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
0.00%
0/37 • 4 years
RECIST criteria
|
|
Musculoskeletal and connective tissue disorders
restless leg syndrome
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
0.00%
0/37 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
anal fungal rash
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
General disorders
seasonal allergies
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
stomatitis
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Respiratory, thoracic and mediastinal disorders
post nasal drip
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Musculoskeletal and connective tissue disorders
bilateral upper extremity lymphedema
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Musculoskeletal and connective tissue disorders
abdominal cramping
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
0.00%
0/37 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
throat pain
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
0.00%
0/37 • 4 years
RECIST criteria
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
5.4%
2/37 • Number of events 2 • 4 years
RECIST criteria
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/6 • 4 years
RECIST criteria
|
23.7%
9/38 • Number of events 9 • 4 years
RECIST criteria
|
21.6%
8/37 • Number of events 8 • 4 years
RECIST criteria
|
|
General disorders
head congestion
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
General disorders
chest congestion
|
0.00%
0/6 • 4 years
RECIST criteria
|
5.3%
2/38 • Number of events 2 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
General disorders
difficulty swallowing
|
0.00%
0/6 • 4 years
RECIST criteria
|
2.6%
1/38 • Number of events 1 • 4 years
RECIST criteria
|
0.00%
0/37 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
BUN elevated
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Musculoskeletal and connective tissue disorders
pleuritic pain
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Injury, poisoning and procedural complications
radiation fibrosis
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
General disorders
right clavicular swelling
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
2.7%
1/37 • Number of events 1 • 4 years
RECIST criteria
|
|
Blood and lymphatic system disorders
Serum amylase increased
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
5.4%
2/37 • Number of events 2 • 4 years
RECIST criteria
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/6 • 4 years
RECIST criteria
|
0.00%
0/38 • 4 years
RECIST criteria
|
8.1%
3/37 • Number of events 3 • 4 years
RECIST criteria
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place