Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
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
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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
- 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.
- 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.
- 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."
- 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."
- 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.
- 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.
- 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.
- 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
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.- STU 062012-053
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
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%
|
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%
|
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%
|
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%
|
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
|
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
|
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
|
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
|
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
|
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
|
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
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 |
Yuanyuan.Zhang@UTSouthwestern.edu |
- STU 062012-053