Clinical trial NCT01757288: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Keywords: STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2012-12-28
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 2-year Overall Survival (Phase II)
timeFrame: 2 years
Secondary outcomes:
measure: The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy
timeFrame: 60 days of the start of treatment
measure: Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy
timeFrame: 1,6,12,18,24 month
measure: Proportion of Participants With Progression-free Survival (Phase II)
timeFrame: 2 years
measure: Median Overall Survival (Phase II)
timeFrame: every 6 months up to 24 months (approx. 22 months)
measure: EuroQol-5Dimension (EQ-5D) MUS Score at Baseline
timeFrame: Baseline
measure: EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment
timeFrame: End of treatment (6 weeks)
measure: EuroQol-5Dimension (EQ-5D) VAS Score at Baseline
timeFrame: Baseline
measure: EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment
timeFrame: End of Treatment (6 weeks)
measure: EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up
timeFrame: 24 month follow up
measure: EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month
timeFrame: 24 month follow up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Pittsburgh
country: United States
facility: UPMC Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Yuanyuan Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: