Head and Neck Neoplasms
Conditions
Keywords
local recurrence and or metastatic disease, Previously treated with platinum, carcinoma of the head and neck
Brief 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.
Detailed description
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.
Interventions
DRUGBAY 43-9006
Sponsors
Jules Bordet Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | — |
Countries
Belgium
Outcome results
None listed