efficacy and activity of bay 43-9006 in patients with recurrent and/or metastatic head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: 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

Keywords: local recurrence and or metastatic disease previously treated with platinum carcinoma of the head and neck