A Randomized Phase I/II Study Of Sorafenib In Combination With High Does Chemoradiation In Patients With Stage IIIA/B Non-small Cell Lung Cancer (NSCLC)
OBJECTIVES:
Primary
- To determine the median survival from randomization for patients receiving carboplatin
and paclitaxel with high-dose radiation therapy (HDRT) or same regimen with sorafenib
tosylate.
Secondary
- To determine the overall response rate, failure-free survival, and survival for
patients receiving carboplatin/paclitaxel with 74 Gy HDRT or same regimen with
sorafenib tosylate.
- To determine the feasibility of concurrent sorafenib tosylate and chemoradiation as
measured by safety (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) and
compliance (the completion of the treatment regimen with no more than minor
variations).
- To correlate outcomes (survival, toxicity, quality of life) with biological parameters.
OUTLINE: This is a multicenter study.
- Phase I:
- Chemoradiotherapy: Patients receive paclitaxel IV over 60 minutes and carboplatin
IV over 30 minutes on day 1. Treatment repeats weekly for 7 weeks. Patients
undergo concurrent high-dose external beam radiotherapy (HDRT) 5 days a week for
7.5 weeks. Cohorts of patients also receive escalating doses of oral sorafenib
tosylate twice daily for 7 weeks.
- Consolidation therapy: Beginning at week 11, patients receive paclitaxel IV over 3
hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks
for 6 weeks. Patients also receive oral sorafenib tosylate at the maximum
tolerated dose (MTD) twice daily.
- Maintenance: Patients receive oral sorafenib tosylate twice daily at the MTD.
- Phase II: Patients are randomized to 1 of 2 treatment arms.
- Arm I:
- Chemoradiotherapy: Patients receive paclitaxel, carboplatin, and HDRT as in
phase I.
- Consolidation therapy: Patients receive paclitaxel and carboplatin as in
phase I.
- Arm II:
- Chemoradiotherapy: Patients receive paclitaxel, carboplatin, and HDRT as in
phase I. Patients also receive oral sorafenib tosylate as in phase I at the
MTD.
- Consolidation therapy: Patients receive paclitaxel, carboplatin, and
sorafenib tosylate at the MTD as in phase I.
- Maintenance: Patients receive sorafenib tosylate at the MTD as in phase I.
After completion of study therapy, patients are followed every 3 months for 2
years and then every 6 months for 2 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Median survival
No
Hak Choy, MD
Study Chair
Simmons Cancer Center
Unspecified
CDR0000571535
NCT00547443
July 2007
Name | Location |
---|---|
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Arlington Cancer Center - Arlington | Arlington, Texas 76012 |