VICC THO 0746 - A Phase I/II Study of Nab-Paclitaxel and Carboplatin With Concurrent Radiation Therapy for Unresectable Stage III Non-Small-Cell Lung Cancer (NSCLC)
- To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle
formulation when combined concurrently with carboplatin and radiation followed by two
courses of paclitaxel albumin-stabilized nanoparticle formulation with carboplatin as
consolidation. (Phase I)
- To evaluate the progression-free survival in patients with stage III unresectable
non-small cell lung cancer treated with paclitaxel albumin-stabilized nanoparticle
formulation, carboplatin, and radiotherapy followed by two courses of paclitaxel
albumin-stabilized nanoparticle formulation with carboplatin as consolidation. (Phase
- To assess safety and tolerability and identify dose-limiting toxicities in patients
receiving paclitaxel albumin-stabilized nanoparticle formulation combined concurrently
with carboplatin and radiotherapy. (Phase I)
- To assess progression-free survival, response rates, and survival. (Phase I)
- To assess overall survival and response rates in all patients treated on this study.
- To assess the safety and tolerability of patients receiving paclitaxel
albumin-stabilized nanoparticle formulation combined concurrently with carboplatin and
radiotherapy followed by two courses of paclitaxel albumin-stabilized nanoparticle
formulation/carboplatin as consolidation. (Phase II)
- To analyze tumor specimens for the secreted protein acidic and rich in cysteine (SPARC)
OUTLINE: This is a multicenter study.
- Phase I:
- Concurrent chemoradiotherapy: Patients receive escalating doses of paclitaxel
albumin-stabilized nanoparticle formulation (nab-paclitaxel) IV over 30 minutes
and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. They also
receive conformal radiotherapy once daily 5 days a week on days 1-5 in weeks 1-7.
Patients are evaluated between weeks 8-10. Patients with disease progression are
removed from study. Patients with stable disease, partial response, or complete
response proceed to consolidation chemotherapy 3 weeks after completion of
- Consolidation chemotherapy: Patients receive nab-paclitaxel IV over 30 minutes on
days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats
ever 21 days for up to 2 courses.
- Phase II: Patients receive concurrent chemoradiotherapy at the MTD of nab-paclitaxel
followed by consolidation chemotherapy as in phase I.
Paraffin embedded blocks from previously performed biopsies or resections from consenting
patients are obtained for SPARC gene expression.
After completion of study treatment, patients are followed at 2 months, every 3 months for 2
years, every 4 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 98 patients (15 patients for phase I and 83 patients for phase
II) will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (phase I)
Vicki Keedy, MD
Vanderbilt-Ingram Cancer Center
United States: Federal Government
VICC THO 0746
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Oregon Health Sciences University||Portland, Oregon|
|Erlanger Cancer Center at Erlanger Hospital - Baroness||Chattanooga, Tennessee 37403|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|
|Purchase Cancer Group - Paducah||Paducah, Kentucky 42001|