Efficacy and Activity of BAY 43-9006 in Patients With Recurrent and/or Metastatic Head and Neck Cancer

This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006 in patients with recurrent and/or metastatic head and neck cancer.

This is a Phase II trial evaluating the efficacy and the biological activity of BAY 43-9006 in patients with recurrent and/or metastatic head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients (18 years old and above), with a histologically proven, measurable, locally recurrent, and/or metastatic head and neck tumor.
* \> 4 weeks since major surgery
* \> 4 weeks since prior chemotherapy
* \> 3 weeks since prior therapy with biological agents (Interleukin-2 \[IL-2\], interferon, other molecular-targeted therapies \[except Ras/Raf inhibitors\]).
* Performance status \< 2
* Life expectancy \> 3 months.
* At least one uni-dimensional measurable lesion by computed tomography (CT)-scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Adequate liver, pancreatic, renal, and coagulation function
* A slide or paraffin-block from a tumor biopsy MUST be available at the time of screening. If the original diagnostic biopsy is not available at the time of screening, an additional biopsy is required.

Exclusion Criteria:

* Severe preexisting conditions
* Evidence of bone marrow suppression
* Frequent vomiting or medical condition, which could interfere with oral medication intake
* Lack of resolution of all toxic manifestations of prior chemotherapy, biologic, or radiation therapy (alopecia excluded).
* Known HIV positivity or AIDS-related illness.
* Previous exposure to a Ras/Raf inhibitor
* Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis and T1\] or other malignancies curatively treated \> 2 years prior to entry)
* Congestive heart failure
* Cardiac arrhythmias requiring anti-arrhythmics
* Active coronary artery disease or ischaemia
* Active clinically serious bacterial or fungal infections
* Known brain or meningeal metastases
* Patients with seizure disorder requiring medication (such as anti-epileptics)
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test.
* Concurrent anti-cancer chemotherapy or immunotherapy is excluded
* Significant surgery within four weeks prior to start of study drug
* Investigational drug therapy outside of this trial, or any chemotherapy during or within 4 weeks prior to start of study drug
* Myelosuppressive radiotherapy within four weeks prior to start of study drug (short-course non-myelosuppressive radiotherapy may be allowed based on approval of principal investigators)
* Concomitant treatment with ketoconazole, itraconazole, ritonavir, or use of grapefruit juice