Phase 2
Completed N=55
Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma · Recurrent Metastatic Squamous Neck Cancer With Occult Primary · Recurrent Salivary Gland Cancer · Recurrent Squamous Cell Carcinoma of the Hypopharynx
Source: ClinicalTrials.gov NCT00939627 ↗
Enrolled (actual)
55
Serious AEs
28.3%
Results posted
Sep 2015
Primary outcomePrimary: Progression Free Survival (PFS) — 3; 3.2 months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
3; 3.2 | — |
| SECONDARY Best Response |
0; 0; 1; 2; 11; 10 | — |
| SECONDARY Overall Survival (OS) |
9; 5.7 | — |
| SECONDARY Number of Participants With Each Worst-Grade Toxicity |
6; 7; 11; 4; 5; 12 | — |
| SECONDARY Gene Expression Levels |
— | — |
| SECONDARY Overall Survival Associated With Immunomodulatory Cytokines |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 = = 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 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
- Any other hemorrhage/bleeding event > CTCAE grade 3 within 4 weeks of first dose of study drug
- Tumor that invades the carotid artery as shown unequivocally by imaging studies
- 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)
- Use of the following medications will not be allowed within 4 weeks prior to enrollment on the study and during the study: ketoconazole, itraconazole, ritonavir, cyclosporine, carbamazepine, phenytoin, phenobarbital; products containing grapefruit juice will not be allowed while on study
- Known or suspected allergy to sorafenib or any agent given in the course of this trial
- Any malabsorption problem
- Known HIV positive patients will be excluded from trial due to the potential immune modulation that these agents may cause
Data sourced from ClinicalTrials.gov (NCT00939627). 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. Informational only — not medical advice.