27
Participants
Start Date
April 30, 2008
Primary Completion Date
December 31, 2013
Study Completion Date
August 31, 2015
Cetuximab
"* Cetuximab dose: based on patient's actual weight. Loading phase dose of cetuximab is 400 mg/m2 IV administered over 120 minutes, on day 1 followed by; Concurrent phase, weekly infusion dose at 250 mg/m2 IV over 60 minutes, on days 8, 15, 22, 29, 36, 43, 50.~* Radiation will be accompanied by weekly Cetuximab. Weekly Cetuximab will start on 1st day of radiation (Day 8). So, total number of cetuximab administrations will vary from 7 to 8. Patients will have every other week complete blood counts (CBCs), differentials, and blood urea nitrogen (BUN) plus creatinine and Mg. If patient's ANC drops below 1,000 and/or the platelet count below 75,000 during CTRT, the corresponding, weekly dose of cetuximab will be omitted."
Conformal Thoracic Radiotherapy (CTRT)
"* Radiation will be accompanied by weekly Cetuximab. Weekly Cetuximab will start on 1st day of radiation (Day 8). So, total number of cetuximab administrations will vary from 7 to 8. Patients will have every other week CBCs, differentials, and BUN plus creatinine and Mg. If patient's ANC drops below 1,000 and/or the platelet count below 75,000 during CTRT, the corresponding, weekly dose of cetuximab will be omitted.~* Radiation therapy will begin on day 8 (with window of ± 3 days). Adequate hematologic profile (ANC \>1,000 and platelets \>75,000) required. Patient may be delayed for a max. of 2 weeks. If \> 2 week delay occurs, patient will come off study."
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER