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

NCT02177838 | Terminated Results DMC

• 4 other identifiers: Pro20150001420NCI-2014-01303031204P30CA072720
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies cetuximab and radiation therapy in treating patients with stage III-IV head and neck cancer. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cetuximab or cisplatin together with radiation therapy may kill more tumor cells.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Locoregional Control in Cetuximab Responders

  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.

  2 years

Secondary Outcomes (2)

• Percent of Patients Who Progress During Neoadjuvant Cetuximab by CT RECIST 1.1 Criteria

  Day 14-21 after the first dose of cetuximab

• Locoregional Control for Non-responders to Neoadjuvant Cetuximab

  2 years

Study Arms (1)

Treatment (cetuximab, cisplatin, EBRT)

EXPERIMENTAL

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.

Biological: cetuximab; Drug: cisplatin; Radiation: external beam radiation therapy; Other: laboratory biomarker analysis

Interventions

cetuximab BIOLOGICAL

Given IV

Also known as: C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225

Treatment (cetuximab, cisplatin, EBRT)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (cetuximab, cisplatin, EBRT)

external beam radiation therapy RADIATION

Undergo EBRT

Also known as: EBRT

Treatment (cetuximab, cisplatin, EBRT)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (cetuximab, cisplatin, EBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven squamous cell carcinoma of the oropharynx, hypopharynx or larynx
• Stage III/IVa/b squamous cell carcinoma (SCC) by American Joint Committee on Cancer (AJCC) 7 criteria (advanced, but not metastatic)
• Patients must give informed consent
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Platelets \>= 100,000/uL
• Absolute neutrophil count (ANC) \>= 1,500/uL
• Hemoglobin \> 8 g/dl (use of transfusion to achieve this is acceptable)
• Total bilirubin \< 2 X institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 X institutional ULN
• Serum creatinine \< 2 x institutional ULN or creatinine clearance \> 50 ml/min as determined by 24 hour collection or estimated by Cockcroft-Gault formula
• Estimated life expectancy of at least 12 weeks
• Negative pregnancy test

You may not qualify if:

• Patients may not have received previous therapy for their head and neck SCC, including chemotherapy, radiation therapy, or surgery beyond biopsy
• Second primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skin
• Patients with metastatic disease beyond the neck and supraclavicular region will be excluded
• Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator; this includes scleroderma
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab or cisplatinum or other agents used in the study
• Women who are pregnant; women of childbearing age must agree to undergo a pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Patients with human immunodeficiency virus (HIV) infection are not automatically excluded, but must meet the following criteria: cluster of differentiation (CD)4 count is \> 499/cu mm and their viral load is \< 50 copies/ml; use of highly active anti-retroviral therapy (HAART) is allowed
• Patients who have had either myocardial infarction, coronary artery bypass graft, coronary artery stenting, hospital admission for heart related issues such as congestive heart failure or arrhythmia within the last 3 months, will not be allowed on protocol
• Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events \[CTCAE\], version \[v\]. 4):
• Serum calcium (ionized or adjusted for albumin) \< 7 mg/dl (1.75 mmol/L) or \> 12.5 mg/dl (\> 3.1 mmol/L) despite intervention to normalize levels
• Magnesium \< 0.9 mg/dl (\< 0.4 mmol/L) or \> 3 mg/dl (\> 1.23 mmol/L) despite intervention to normalize levels
• Potassium \< 3.5 mmol/L or \> 6 mmol/L despite intervention to normalize levels
• Sodium \< 130 mmol/L or \> 155 mmol/L despite intervention to normalize levels

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (1)

New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Cetuximab; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

Early termination of the trial led to a small number of subjects analyzed.

Results Point of Contact

• Title: Sung Kim, MD
• Organization: Rutgers Cancer Institute of New Jersey

sk1375@cinj.rutgers.edu

732-235-3986

Study Officials

• Sung Kim

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency & Clinical Director

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 30, 2014
• Study Start: March 25, 2015
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: April 21, 2021
• Results First Posted: January 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)