Safety and Efficacy (Phase II) Study of Concurrent Cetuximab Plus Conformal Thoracic Radiotherapy in (Poor Prognosis) Patients With Inoperable or Unresectable, Locally Advanced Non-Small Cell Lung Cancer (LA - NSCLC)
Patients will be asked to spend about six months in this study. There will be 4 different
phases in this study as follows: (1) Loading Phase: This is the first week (week 1) of the
study, when patients receive their first (loading) dose of cetuximab only, in the vein. (2)
Concurrent Phase: During this phase patients will be treated simultaneously (concurrently)
with radiation therapy to their chest and cetuximab. Radiation is delivered 5 days a week,
Monday to Friday for a total of 7 weeks (weeks 2-8). Cetuximab is delivered in the vein,
weekly, during the weeks of radiation. (3) Recovery Phase: Patients receive no treatment
during these next 3 weeks (weeks 9-11). This phase is designed to allow patients to recover
from side effects before they start the last phase. (4) Consolidation Phase: The last phase.
Patients will receive 3 doses of chemotherapy with docetaxel during this phase. Docetaxel is
given intravenously every 21 days. Patients also receive weekly cetuximab during this phase.
Cetuximab is delivered in a similar way as it was during the concurrent (second) phase of
this study. In total, this phase lasts 6 weeks (weeks 12-18). Once the therapy treatment is
completed, and if the patient's cancer did not get worse, follow up visits will include
visits to their physician every three months for 2 years, then every 4 months for 2 years or
more, as long as their cancer doesn't get worse (at which time they will be removed from the
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Progression Free Survival
Determine the progression free survival (PFS) of concurrent cetuximab plus conformal thoracic radiotherapy (CTRT) and consolidation docetaxel plus cetuximab, in newly diagnosed patients with inoperable or unresectable, LA-NSCLC and poor prognostic characteristics.
Alberto Chiappori, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|