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

Free University of Brussels (ULB)

Status and phase

Completed

Phase 2

Conditions

Head and Neck Neoplasms

Treatments

Drug: BAY 43-9006

Study type

Interventional

Funder types

Other

Identifiers

NCT00199160

BAY 43-9006 Head and Neck

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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