This is an open label, phase II study in which cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab will be administered to subjects with locally advanced NSCLC.
This is a Phase II study to determine the overall survival for patients with locally advanced NSCLC treated with cetuximab with concurrent thoracic radiotherapy followed by consolidation chemotherapy with paclitaxel/carboplatin/cetuximab. This is a multicenter study including 36 subjects who will be males and females, both greater than 18 years of age. All subjects will initially receive radiation and cetuximab. Radiation will be given once a day (Monday-Friday) for approximately 6-8 weeks. During the course of radiation, cetuximab will be given intravenously once a week. Approximately 4-6 weeks after the last radiation dose, the subjects will be treated with chemotherapy, paclitaxel/carboplatin. Chemotherapy will be given intravenously once every 3 weeks for 3 cycles (1 cycle=3 weeks). Cetuximab intravenous administration will be continued throughout the entire study, once a week through week 26 including during chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The initial dose of cetuximab is 400 mg/m2 intravenously administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Subjects will receive cetuximab from week 0 through week 26.
Overall Survival (OS)
Time frame: Up to 36 months
Progression-free Survival (PFS)
Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. Progressive Disease was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: Up to 36 months
Best Overall Response Rate (ORR) (Number of Participants)
The Best Overall Response is the best response (Complete Response, Partial Response, Stable Disease, Progressive Disease) recorded from the start of the study treatment until the disease progression/recurrence at end of study. Response and progression were evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. Complete Response (CR) is the Disappearance of all target lesions and Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time frame: Up to 12 weeks after treatment initiation
EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase
EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.
Time frame: approx. 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sylvester Comprehensive Cancer Center, University of Miami
Miami, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States
UPMC Cancer Center -Teramana Cancer Center
Steubenville, Ohio, United States
UPMC Cancer Center -Beaver
Beaver, Pennsylvania, United States
UPMC Cancer Center - Clairton
Clairton, Pennsylvania, United States
UPMC Cancer Center - Oakbrook Commons
Greensburg, Pennsylvania, United States
UPMC Cancer Center -Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
Penn State Cancer Institute, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
UPMC Cancer Center -Indiana
Indiana, Pennsylvania, United States
...and 21 more locations