Tongue Cancer Clinical Trial
Official title:
Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab in Patients With Refractory, Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cetuximab is more effective when given alone or together with sorafenib tosylate in treating patients with head and neck cancer. This randomized phase II trial is studying cetuximab to see how well it works when given together with or without sorafenib tosylate in treating patients with refractory, recurrent, and/or metastatic head and neck cancer.
PRIMARY OBJECTIVES:
I. Compare the progression free survival (PFS) of the combination of cetuximab and sorafenib
to that of cetuximab alone in patients with recurrent, refractory or metastatic squamous cell
carcinoma of the head and neck (SCCHN).
SECONDARY OBJECTIVES:
I. To evaluate the response rate, overall survival (OS) and toxicity of the combination of
cetuximab and sorafenib and of cetuximab alone.
II. To evaluate the presence of EGFRvIII mutation, increased EGFR gene copy number and
activated EGFR gene expression signature, and correlate with clinical parameters (RR, OS and
PFS) in the cetuximab alone and cetuximab/sorafenib arms.
III. To evaluate whether VEGF receptor family and their ligand expression can predict
response to cetuximab/sorafenib.
IV. To determine the proteomic profiles in serum and tumors that can predict the response and
survival upon the treatment with cetuximab or cetuximab/sorafenib.
V. To evaluate the effect of therapy on both general and head and neck specific
functionality, symptom burden and QOL.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral
placebo twice daily on days 1-21. (oral placebo closed as of 02/18/2010).
ARM II: Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral
sorafenib tosylate twice daily on days 1-21.
In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Paraffin embedded tissue samples are collected at baseline for pharmacogenomic studies and
blood samples are collected at baseline and for the first 3 courses for research purposes.
Quality of life and symptom burden are assessed by Vanderbilt Head and Neck Symptom Survey,
FACT-HN, and Fatigue and Pain Inventory questionnaires at baseline, at day 43, and at 3 and 6
months.
After completion of study treatment, patients are followed periodically for 3 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01469429 -
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04041141 -
Oral Stent Device for Radiation Treatments of Oral Cancers
|
||
| Completed |
NCT00049283 -
Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00407810 -
Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00096512 -
S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT01637194 -
Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00033618 -
Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck
|
Phase 2 | |
| Completed |
NCT01816841 -
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
|
N/A | |
| Recruiting |
NCT04028479 -
The Registry of Oncology Outcomes Associated With Testing and Treatment
|
||
| Completed |
NCT04059861 -
Ultrasound in Tongue Cancer- a Help to Decide Depth of Invasion and to Improve the Surgical Margin
|
N/A | |
| Recruiting |
NCT01854021 -
Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
|
N/A | |
| Completed |
NCT01816984 -
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT01674374 -
Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy
|
Phase 2 | |
| Terminated |
NCT01528137 -
Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT04337853 -
Radiotherapy of Tongue Cancer Using an Intraoral Stent
|
Phase 1 | |
| Completed |
NCT01806675 -
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01847326 -
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer
|
Phase 1 | |
| Terminated |
NCT02177838 -
Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer
|
N/A | |
| Completed |
NCT00114283 -
Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT04126226 -
Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy
|
N/A |