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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
Phase 1, PHASE2 trial testing NAB-PACLITAXEL in STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER in 98 participants. Completed in 3 June 2019.
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 98 |
| Start date | 25 March 2013 |
| Primary completion | 3 June 2019 |
| Estimated completion | 3 June 2019 |
| Sites | 5 locations across United States |
University of Texas Southwestern Medical Center
Adults 18 to 99, any sex, with STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 66.5 | 48.4 – 79.5 |
| NAB-PACLITAXEL (Phase II, Arm B) | 55.5 | 36.3 – 71.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| NAB-PACLITAXEL (Phase I) | 0 |
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
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 36.8 | 21.8 – 54.0 |
| NAB-PACLITAXEL (Phase II, Arm B) | 45.9 | 29.5 – 63.1 |
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 21.1 | 9.6 – 37.3 |
| NAB-PACLITAXEL (Phase II, Arm B) | 24.3 | 11.8 – 41.2 |
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 10.5 | 2.9 – 24.8 |
| NAB-PACLITAXEL (Phase II, Arm B) | 13.5 | 4.5 – 28.8 |
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 10.5 | 2.9 – 24.8 |
| NAB-PACLITAXEL (Phase II, Arm B) | 5.4 | 0.7 – 18.2 |
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 2.6 | 0.1 – 13.8 |
| NAB-PACLITAXEL (Phase II, Arm B) | 8.1 | 1.7 – 21.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 44.4 | 27.6 – 59.9 |
| NAB-PACLITAXEL (Phase II, Arm B) | 27.3 | 13.7 – 42.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | NA | 0 – 0 |
| NAB-PACLITAXEL (Phase II, Arm B) | 27.8 | 16.8 – 37.8 |
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."
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 0.49 | 0.40 – 0.57 |
| NAB-PACLITAXEL (Phase II, Arm B) | 0.44 | 0.39 – 0.50 |
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."
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 0.55 | 0.44 – 0.67 |
| NAB-PACLITAXEL (Phase II, Arm B) | 0.45 | 0.39 – 0.52 |
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.
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 0.80 | 0.72 – 0.88 |
| NAB-PACLITAXEL (Phase II, Arm B) | 0.79 | 0.72 – 0.87 |
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.
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 0.64 | 0.50 – 0.79 |
| NAB-PACLITAXEL (Phase II, Arm B) | 0.78 | 0.71 – 0.86 |
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.
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 0.6 | 0.6 – 0.6 |
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."
| Group | Value | 95% CI |
|---|---|---|
| PACLITAXEL (Phase II, Arm A) | 0.47 | 0.47 – 0.47 |
Time frame: 4 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NAB-PACLITAXEL (Phase I) | PACLITAXEL (Phase II, Arm A) | NAB-PACLITAXEL (Phase II, … |
|---|---|---|---|---|
| fatigue | General disorders | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — |
| decreased neutrophil count | Blood and lymphatic system disorders | — | — | — |
| neutrophil count decreased | Blood and lymphatic system disorders | — | — | — |
| lymphocyte count decreased | Blood and lymphatic system disorders | — | — | — |
| platelet count decreased | Blood and lymphatic system disorders | — | — | — |
| decreased WBC | Blood and lymphatic system disorders | — | — | — |
| decreased platelet count | Blood and lymphatic system disorders | — | — | — |
| dyspnea | General disorders | — | — | — |
| anorexia | Gastrointestinal disorders | — | — | — |
| cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| nausea | Metabolism and nutrition disorders | — | — | — |
| dysphagia | General disorders | — | — | — |
| esophagitis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| dercreased lymphocytes | Blood and lymphatic system disorders | — | — | — |
| constipation | Gastrointestinal disorders | — | — | — |
| albumin decreased | Blood and lymphatic system disorders | — | — | — |
| dermatitis | General disorders | — | — | — |
| hyponatremia | Blood and lymphatic system disorders | — | — | — |
| alopecia | Immune system disorders | — | — | — |
| Fever | General disorders | — | — | — |
| dizziness | Nervous system disorders | — | — | — |
| vomiting | Gastrointestinal disorders | — | — | — |
| diarrhea | Gastrointestinal disorders | — | — | — |
| GERD | Gastrointestinal disorders | — | — | — |
| creatnine elevated | Blood and lymphatic system disorders | — | — | — |
| dehydration | General disorders | — | — | — |
| dysgeusia | Metabolism and nutrition disorders | — | — | — |
| sore throat | Respiratory, thoracic and mediastinal disorders | — | — | — |
| alanine aminotransferase increased | Blood and lymphatic system disorders | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — |
| Alkaline phosphatase increased | Blood and lymphatic system disorders | — | — | — |
| aspartate aminotransferase increased | Blood and lymphatic system disorders | — | — | — |
| thromboembolic event | Blood and lymphatic system disorders | — | — | — |
| epistaxis | General disorders | — | — | — |
| urinary tract infection | Infections and infestations | — | — | — |
| arthralgias | General disorders | — | — | — |
| dry mouth | General disorders | — | — | — |
| chest wall pain | Musculoskeletal and connective tissue disorders | — | — | — |
| pleural effusion | General disorders | — | — | — |
Data from ClinicalTrials.gov NCT01757288 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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