Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab
5 other identifiers
interventional
55
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2009
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
September 1, 2015
CompletedMarch 10, 2026
December 1, 2017
3.5 years
July 14, 2009
July 28, 2014
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
On-study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)
Secondary Outcomes (5)
Best Response
On-treatment date to date of disease progression (assessed up to 3 years)
Overall Survival (OS)
On-study date to date of death from any cause (assessed up to 3 years)
Number of Participants With Each Worst-Grade Toxicity
On-study date to 30 days following final dose of study drug
Gene Expression Levels
Pre-therapy
Overall Survival Associated With Immunomodulatory Cytokines
Pre-therapy, up to about 42 months (follow-up for overall survival)
Other Outcomes (1)
Quality of Life
up to 3 years
Study Arms (2)
Arm I (cetuximab and placebo)
PLACEBO COMPARATORPatients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21.
Arm II (cetuximab and sorafenib tosylate)
EXPERIMENTALPatients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
Interventions
Given IV
Given orally
Correlative studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- Patients with recurrent, refractory or metastatic squamous cell carcinoma of oral cavity, oropharynx and larynx, hypopharynx or paranasal sinus, head and neck unknown primary or nasopharyngeal carcinoma WHO type 1; patients with recurrent, refractory or metastatic squamous cell carcinoma of oral cavity, oropharynx and larynx, hypopharynx or paranasal sinus, head and neck unknown primary or nasopharyngeal carcinoma WHO type 1; patients may have had up to 1 prior palliative chemotherapy for recurrent or metastatic disease; please note that chemotherapy given as part of a regimen for curative intent for recurrent disease does not count as "prior chemotherapy;" patients must not presently be candidates for curative therapy
- ECOG performance status 0, 1 or 2
- Hemoglobin \>= 9.0/dl
- Absolute-neutrophil count (ANC) \>= 1500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Total bilirubin =\< 1.5 x ULN
- ALT and AST =\< 2.5 x ULN (=\< 5 x ULN for patients with liver involvement)
- INR \< 1.5 or a PT and PTT within normal limits
- Creatinine =\< 1.5 x ULN
- If primary therapy was given for curative intent, at least 4 weeks must have elapsed after completion of primary therapy prior to enrollment on this clinical trial; however, toxicities from prior treatment must have resolved to grade 1 or less
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of the treatment; women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation (i.e, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for a minimum of 3 months following the last dose of chemotherapy; male subject agrees to use an acceptable method for contraception for the duration of the study and for a minimum of 3 months following the last dose of chemotherapy
- Patients must have a measurable disease defined by RECIST criteria
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care; patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
You may not qualify if:
- Prior treatment with sorafenib or cetuximab
- Patients with active clinically significant infection or with a fever \>= 38.5º C within 3 days of the first scheduled day of protocol treatment
- History of prior malignancy within the past 3 years except for curatively treated basal cell carcinoma and squamous cell carcinoma of the skin, CIN or localized prostate cancer with a current PSA \< 1.0 mg/dL on 2 successive evaluations at least 3 months apart, with the most recent evaluation within 4 weeks of study entry
- Patients with known hypersensitivity to sorafenib or cetuximab
- Prior severe infusion reaction to a monoclonal antibody
- History of hand-foot syndrome
- Pregnant or lactating; sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized
- Known untreated brain metastasis; patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis or progression of brain metastasis; patients with treated brain metastasis are eligible for study as long as no evidence of progression of CNS disease; hemorrhagic brain metastases are not allowed on study
- Uncontrolled comorbid illness
- Patients with HIV who are taking antiretroviral mediations will be excluded because of the potential interactions of anti-retroviral medications with these agent; however, given the potential immune modulating effects of sorafenib, investigators should still be very cautious about placing HIV positive patients on this trial as the effects of these medications on the HIV virus itself are not know
- History of allogeneic transplant
- Patient has received other investigational drugs within 28 days before enrollment
- Cardiac disease: congestive heart failure \> class II NYHA; patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months; significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension (defined as defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction will also be excluded from study; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy will also be excluded from study
- Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event \> CTCAE grade 2 within 4 weeks of first dose of study drug
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
Billings Clinic
Billings, Montana, 59107-7000, United States
Montefiore Medical Center
The Bronx, New York, 10467-2490, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
PMID: 25057165DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Accrual ended early based on planned interim analysis, but the study was completed with existing participants.
Results Point of Contact
- Title
- Jill Gilbert, M.D.
- Organization
- Vanderbilt Ingram Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jill Gilbert
H. Lee Moffitt Cancer Center and Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 15, 2009
Study Start
July 1, 2009
Primary Completion
January 1, 2013
Study Completion
January 1, 2014
Last Updated
March 10, 2026
Results First Posted
September 1, 2015
Record last verified: 2017-12