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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jules Bordet Institute
• Treatments: Sorafenib

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