Description:
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 with carboplatin concurrent with daily radiation.
Title
- 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)
Clinical Trial IDs
- ORG STUDY ID:
STU 062012-053
- NCT ID:
NCT01757288
Conditions
- STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Interventions
Drug | Synonyms | Arms |
---|
NAB-PACLITAXEL | Abraxan | NAB-PACLITAXEL |
PACLITAXEL | | PACLITAXEL |
Purpose
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 with carboplatin concurrent with daily radiation.
Trial Arms
Name | Type | Description | Interventions |
---|
PACLITAXEL | Active Comparator | PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY | |
NAB-PACLITAXEL | Experimental | NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY | |
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
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 2-year overall survival from randomization for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | the feasibility of concurrent carboplatin/nab-paclitaxel and radiation therapy |
Time Frame: | 60 days of the start of treatment |
Safety Issue: | |
Description: | Safety is measured by the rate of 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 is defined as the completion of the treatment regimen with no more than minor variations. |
Measure: | overall response rate for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | the progression-free survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | the median overall survival for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | quality of life (QOL) of patients receiving either nab-paclitaxel or paclitaxel when given with concurrent radiotherapy |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | correlate outcomes (survival, toxicity, QOL) with biological parameters |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | University of Texas Southwestern Medical Center |
Trial Keywords
- STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Last Updated
August 20, 2020