Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

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

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.

Eligibility: 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

Relevance to patient case: not relevant