Phase 2 N=28 Treatment

Study of Sorafenib/Cetuximab in Head and Neck Cancer

Squamous Cell Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00815295 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Dec 2014

Primary outcome: Primary: Phase 1 - Maximum Tolerated Dose (MTD) of Sorafenib Administered With Cetuximab (400 mg/m2 Loading Dose Followed by 250 mg/m2 Weekly) — 400 mg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sorafenib (Drug); Cetuximab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Phase 1 - Maximum Tolerated Dose (MTD) of Sorafenib Administered With Cetuximab (400 mg/m2 Loading Dose Followed by 250 mg/m2 Weekly)	400	—
PRIMARY Tumor Control Rate	43.8	—
SECONDARY Median Survival	9.3	—
SECONDARY Median Progression-Free Survival (PFS)	5.6	—
SECONDARY Phase 2 - Mean Change From Baseline in Quality of Life - Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N)	—	—

Summary

In this Phase I B/II trial, we seek to determine the safety and efficacy of sorafenib with standard dose cetuximab in the treatment of patients with Recurrent and /or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Eligibility Criteria

Inclusion Criteria

Histologically confirmed squamous cell carcinoma of the head and neck
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Age > 18 years old
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Adequate bone marrow, liver and renal function as assessed by the following:
Hemoglobin > 9.0 g/dl
Absolute neutrophil count (ANC) > 1,500/mm3
Platelet count > 100,000/mm3
Total bilirubin class II New York Heart Association (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.
Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
Active clinically serious infection > Common Terminology Criteria for Adverse events (CTCAE) Grade 2.
Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 (symptomatic and requiring medical intervention) within 4 weeks of first dose of study drug.
Any other hemorrhage/bleeding event > CTCAE Grade 3 (bleeding requiring blood transfusion or intervention with endoscopy or surgery) within 4 weeks of first dose of study drug.
Serious non-healing wound, ulcer, or bone fracture.
Evidence or history of bleeding diathesis or coagulopathy Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
Use of St. John's Wort or rifampin (rifampicin).
Known or suspected allergy to sorafenib or any agent given in the this trial.
Any malabsorption problem.
Previous therapy with cetuximab for the treatment of recurrent and/or metastatic SCCHN. Previous therapy with cetuximab during definitive radiation therapy for locally advanced SCCHN is permitted so long as relapse of SCCHN occurred at least > 6 months (180 days) from the end of cetuximab therapy.
Previous therapy with sorafenib, sunitinib or another small molecule known to inhibit the vascular endothelial growth factor receptors.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00815295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.