Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT02177838|
Recruitment Status : Terminated (Slow accrual)
First Posted : June 30, 2014
Results First Posted : January 15, 2021
Last Update Posted : January 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stage III Squamous Cell Carcinoma of the Hypopharynx Stage III Squamous Cell Carcinoma of the Larynx Stage III Squamous Cell Carcinoma of the Oropharynx Stage III Verrucous Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IVA Squamous Cell Carcinoma of the Larynx Stage IVA Squamous Cell Carcinoma of the Oropharynx Stage IVA Verrucous Carcinoma of the Larynx Stage IVB Squamous Cell Carcinoma of the Larynx Stage IVB Squamous Cell Carcinoma of the Oropharynx Stage IVB Verrucous Carcinoma of the Larynx Tongue Cancer||Biological: cetuximab Drug: cisplatin Radiation: external beam radiation therapy Other: laboratory biomarker analysis||Not Applicable|
I. 2 year (yr) locoregional control in cetuximab responders.
I. Assess secondary clinical endpoints such as the percent of patients receiving neoadjuvant cetuximab who progress by computed tomography (CT) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria during the neoadjuvant cetuximab, the 2 yr locoregional control for non-responders to neoadjuvant cetuximab, and the complete response rate to positron emission tomography (PET)/computed tomography (CT) scan 3 months after the completion of radiation therapy for both responders and for non-responders to neoadjuvant cetuximab.
II. Analyze the relationship of known deoxyribonucleic acid (DNA) mutations in tumor per the FoundationOne genomic profile, and correlate to clinical endpoints such as locoregional control.
II. Analyze any changes in protein production at the tumor in response to 3 weeks of cetuximab.
III. Analyze any changes in protein production at the skin in response to 3 weeks of cetuximab.
IV. To investigate whether the tumor imaging characteristics including anatomical and molecular parameters evaluated by PET/CT, either alone or combined with other biomarkers can attribute to the better prediction for the clinical outcomes, as the response to neoadjuvant cetuximab; and the final clinical endpoint, the 2-year local regional controls.
Patients receive cetuximab intravenously (IV) over 60-120 minutes for 3 weeks. Patients then undergo external beam radiation therapy (EBRT) over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.
After completion of study treatment, patients are followed up every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Selecting for Cetuximab Responders in Advanced Head and Neck SCC|
|Actual Study Start Date :||March 25, 2015|
|Actual Primary Completion Date :||August 22, 2019|
|Actual Study Completion Date :||August 22, 2019|
Experimental: Treatment (cetuximab, cisplatin, EBRT)
Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.
Radiation: external beam radiation therapy
Other Name: EBRT
Other: laboratory biomarker analysis
- Locoregional Control in Cetuximab Responders [ Time Frame: 2 years ]
Target number of patients for the study was 27. At the termination of the study, 8 patients were accrued and finished treatment but 1 patient dropped out before follow up, leaving an evaluable number of 7. As the enrollment in the study did not reach the target number of patients, we were not able to produce statistically reliable results to detect the expected difference. Therefore, we have decided to provide summary statistics of primary and secondary outcomes.
Among 3 cetuximab responders, two did not have progression within 2 year follow-up time and one had a locoregional recurrence and expired.
- Percent of Patients Who Progress During Neoadjuvant Cetuximab by CT RECIST 1.1 Criteria [ Time Frame: Day 14-21 after the first dose of cetuximab ]Among 7 patients, no one progressed during neoadjuvant cetuximab per RECIST 1.1 CT criteria (0%).
- Locoregional Control for Non-responders to Neoadjuvant Cetuximab [ Time Frame: 2 years ]Among 4 cetuximab non-responders, none had locoregional failure at 2 years. Two patients had known HPV status; one patient was HPV+ and another patient HPV-. HPV status for the other two was unknown. HPV positive patient had no sign of progression within 2 years of follow-up. HPV negative patient had no sign of progression for 210 days until the last follow-up. One HPV unknown patient did not show progression within 2 years of follow-up, and the other HPV unknown patient had no progression for 115 days until the last follow-up.
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): NCT02177838
|United States, New Jersey|
|New Jersey Medical School|
|Newark, New Jersey, United States, 07103|
|Principal Investigator:||Sung Kim||Rutgers Cancer Institute of New Jersey|