Trial Outcomes & Findings for Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer (NCT NCT02177838)

Last Updated: 2021-04-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

2 years

Results posted on

2021-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	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. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
Overall Study STARTED	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1
Overall Study Death	1

Baseline Characteristics

Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Cetuximab, Cisplatin, EBRT) n=8 Participants 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. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment (Cetuximab, Cisplatin, EBRT) n=7 Participants 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. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
Locoregional Control in Cetuximab Responders	7 Participants

SECONDARY outcome

Timeframe: Day 14-21 after the first dose of cetuximab

Population: This measure what not evaluated because the study was halted prematurely due to low accrual.

Among 7 patients, no one progressed during neoadjuvant cetuximab per RECIST 1.1 CT criteria (0%).

Outcome measures

Outcome measures
Measure	Treatment (Cetuximab, Cisplatin, EBRT) n=7 Participants 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. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
Percent of Patients Who Progress During Neoadjuvant Cetuximab by CT RECIST 1.1 Criteria	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: This measure what not evaluated because the study was halted prematurely due to low accrual.

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.

Outcome measures

Outcome measures
Measure	Treatment (Cetuximab, Cisplatin, EBRT) n=4 Participants 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. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
Locoregional Control for Non-responders to Neoadjuvant Cetuximab	0 Participants

Adverse Events

Treatment (Cetuximab, Cisplatin, EBRT)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Cetuximab, Cisplatin, EBRT) n=8 participants at risk 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. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders Dysphagia	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.

Other adverse events

Other adverse events
Measure	Treatment (Cetuximab, Cisplatin, EBRT) n=8 participants at risk 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. cetuximab: Given IV cisplatin: Given IV external beam radiation therapy: Undergo EBRT laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders Dry mouth	37.5% 3/8 • Number of events 3 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Gastrointestinal disorders Dysphagia	87.5% 7/8 • Number of events 7 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
General disorders Fatigue	25.0% 2/8 • Number of events 2 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Blood and lymphatic system disorders Lymphocyte count decreased	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Blood and lymphatic system disorders Neutrophil count decreased	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Blood and lymphatic system disorders White blood cell count decreased	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Gastrointestinal disorders Anorexia	87.5% 7/8 • Number of events 7 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Gastrointestinal disorders Dehydration	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Musculoskeletal and connective tissue disorders Pain	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Nervous system disorders Dysgeusia	50.0% 4/8 • Number of events 4 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
General disorders Pain	62.5% 5/8 • Number of events 5 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Skin and subcutaneous tissue disorders Pruritus	25.0% 2/8 • Number of events 2 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.
Skin and subcutaneous tissue disorders Rash acneform	12.5% 1/8 • Number of events 1 • All patients who received one dose of protocol therapy were evaluated for assessment of toxicity. All adverse events, whether observed by the treating physician or reported by the patient, occurring during the active portion of therapy or up to 30 days after the last dose of treatment were captured.

Additional Information

Sung Kim, MD

Rutgers Cancer Institute of New Jersey

Phone: 732-235-3986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place