A Phase II Study of Induction Chemotherapy With Paclitaxel and Carboplatin Followed by Radiation Therapy With RSR13 for Locally Advanced Inoperable Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine the one year survival rate, two year survival rate, and median
survival rate in patients with locally advanced unresectable non-small cell lung cancer
treated with paclitaxel and carboplatin followed by radiotherapy plus RSR13. II. Determine
the complete and partial response rates and progression free interval in the chest
(radiation portal) of these patients on this regimen. III. Determine the time to disease
progression outside of the radiation portal in these patients on this regimen. IV. Determine
the toxic effects and adverse events associated with this regimen in these patients.
OUTLINE: This is a multicenter study. Induction chemotherapy: Patients receive paclitaxel IV
over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses. Radiotherapy:
Beginning 3 to 4 weeks after induction chemotherapy, patients receive RSR13 IV over 30
minutes, followed by fractionated radiotherapy 5 times weekly for 6-7 weeks. Patients are
followed monthly for 2 months and then every 3 months thereafter until disease progression
or death.
PROJECTED ACCRUAL: A total of 46-48 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Hak Choy, MD
Study Chair
Vanderbilt-Ingram Cancer Center
United States: Federal Government
CDR0000067445
NCT00004202
October 1998
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
Boston Cancer Group | Memphis, Tennessee 38119 |
Cedars-Sinai Comprehensive Cancer Center | Los Angeles, California 90048 |
Dan Rudy Cancer Center | Nashville, Tennessee 37205 |