Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer (NCT02177838) | Clinical Trial Compass
TerminatedNot Applicable
Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer
Stopped: Slow accrual
United States8 participantsStarted 2015-03-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 supraclavicul…
What they're measuring
1
Locoregional Control in Cetuximab Responders
Timeframe: 2 years
Trial details
NCT IDNCT02177838
SponsorRutgers, The State University of New Jersey