Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC
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|ClinicalTrials.gov Identifier: NCT00492206|
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : February 1, 2017
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer (NSCLC)||Drug: Cetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Cetuximab in Combination With External Beam Radiation Followed By Consolidation Chemotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Cetuximab 400 mg/m2 IV week 0 only
External beam radiation weeks 1 - 7
Cetuximab 250 mg/m2 IV weekly thereafter weeks 1 - 7
Cetuximab 250 mg/m2 IV weekly weeks 8 - 26
Carboplatin AUC = 6 IV Paclitaxel 200 mg/m2 IV Every 3 weeks x 3 Cycles
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.
Other Name: Erbitux, C225
- Overall Survival (OS) [ Time Frame: Up to 36 months ]
- Progression-free Survival (PFS) [ Time Frame: Up to 36 months ]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.
- Best Overall Response Rate (ORR) (Number of Participants) [ Time Frame: Up to 12 weeks after treatment initiation ]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.
- EGFR (Epidermal Growth Factor Receptor) Gene Mutation and Akt, pAkt, and MAPKinase [ Time Frame: approx. 5 years ]EGFR (epidermal growth factor receptor) gene mutation status and Akt, pAkt, and MAPKinase in participant tumor tissue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492206
|Principal Investigator:||Athanassios Argiris, MD||University of Pittsburgh|