PhII Study of Concurrent Chemoradiotherapy With Weekly Docetaxel, Carboplatin and Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel and Carboplatin for Locally Advanced Inoperable Non-small Cell Lung Cancer (NSCLC)
- To determine the overall survival (0S) for advanced NSCLC patients receiving concurrent
chemoradiotherapy with weekly docetaxel, carboplatin and radiation therapy followed by
two cycles of consolidation chemotherapy with docetaxel and carboplatin.
- To determine the overall response rate in patients treated with this regimen.
- To determine the time to disease progression in patients treated with this regimen.
- To assess the safety and tolerability of this regimen in these patients.
- This is a Phase II, open label, multi-center study to determine the overall survival
rate for patients treated with concurrent chemoradiotherapy with weekly docetaxel,
carboplatin and radiation followed by two cycles of consolidation chemotherapy with
docetaxel and carboplatin. Eligible patients will receive concurrent therapy with
docetaxel (20 mg/m2) administered weekly for seven weeks as a 30-minute intra-venous
(IV) infusion followed by carboplatin (AUC 2) administered weekly for seven weeks as a
30-minute IV infusion. Concurrent radiation therapy will be administered at a dose of
1.8 Gy daily 5 days/week for 25 fractions followed by a dose of 2.0 Gy daily, 5
days/week for 9 fractions (total of 34 fractions). There will be a three-week rest
period following the end of the concurrent chemotherapy after which the consolidation
phase will begin. During this phase of the study, patients will be treated with
docetaxel (75 mg/m2) administered as a 1-hour IV infusion followed by carboplatin (AUC
6) administered as a 30-minute IV infusion. Patient will be treated every three weeks
for a total of two cycles.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Months from on-study to expired/last date known alive.
14.95 months (average duration, on study date to off-study date)
Vicki Keedy, MD
Vanderbilt-Ingram Cancer Center
United States: Federal Government
VICC THO 0319
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Swedish Cancer Institute||Seattle, Washington 98104|
|Tennessee Cancer Specialists||Knoxville, Tennessee 37920|
|St. Thomas Health Services||Nashville, Tennessee 37205|
|Meharry Medical College||Nashville, Tennessee 37208-3599|
|The West Clinic, PC||Memphis, Tennessee 38120|
|Erlanger Health System||Chattanooga, Tennessee 37403|
|Ut Southwestern Medical Center||Dallas, Texas 75390|
|University Hospital of Cleveland||Cleveland, Ohio 44106|
|Chesapeake Oncology Hematology Associates||Baltimore, Maryland 21225|
|University of Tennessee Medical Center||Knoxville, Tennessee 37920|
|M.D. Anderson Cancer Center, Orlando||Orlando, Florida 32806|
|Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center||Allentown, Pennsylvania 18103|
|Clarksville Regional Hematology Oncology Group||Clarksville, Tennessee 37043|
|Jackson Madison County Hospital||Jackson, Tennessee 38301|