PROTOCOL # 06-C-0164: A Phase II Study of BAY 43-9006 (Sorafenib) in Combination with Cetuximab (Erbitux®) in EGFR Expressing Metastatic Colorectal Cancer
Researchers at the National Cancer Institute want to know if they can improve the number of patients who respond to Erbitux® (cetuximab) by adding a second agent to it.
Patients with metastatic colorectal cancer who have already had at least one type of chemotherapy are being sought for a phase II clinical trial combining oral sorafenib (BAY 43-9006 or Nexavar®) with intravenous cetuximab. Nexavar® targets and blocks proteins that are important in the growth and multiplication of cancer cells. It is already approved by the FDA to treat kidney cancer.
Eligible patients include those who
- have metastatic colorectal cancer
- have had at least one previous chemotherapy and cancer progression
- have not been treated with either Erbitux or sorafenib
- have at least one measurable tumor
- do not have brain metastases
- are not eligible for surgical removal of their metastatic tumor
- can swallow pills
Patients on the clinical trial will be treated at the NIH Clinical Center in Bethesda, MD. There is no cost for treatment at the Clinical Center and funds are available to help with transportation and lodging during outpatient visits.
Patients will spend the first 2-3 days in the hospital to get treatment underway. After that, treatment will be part of weekly outpatient clinic visits. There is a possibility that local oncologists can administer cetuximab after the first cycle, reducing some travel to Bethesda.
More information about enrolling in the trial is available from:
Laura D. Otten, R.N., B.S.N., O.C.N.
Medical Oncology Referral Coordinator
Phone: 301-451-1228
1-866-611-6310 (Toll Free)
ottenl@mail.nih.gov
or
Janelle Bingham, R.N.
Research Nurse
Phone: 301-435-2715
jbingham@mail.nih.gov
Dr. Shivaani Kummar is the physician-scientist responsible for the trial.
To contact her:
Shivaani Kummar, M.D.
Principal Investigator
Phone: 301-435-5402
kummars@mail.nih.gov
Leave a Reply
Your comments are welcome. However, specific medical advice will not be provided, and we urge you to consult with a qualified physician for diagnosis and for answers to your personal questions. FightCRC is not responsible for the medical accuracy of any comments left by persons other than FightCRC staff members. FightCRC staff members monitor comments and may respond publicly where appropriate.
Please note that we automatically publish the name that you enter next to your post. Also note that our pages are automatically indexed by Google and other search engines, and your name may therefore appear in search results on those sites. So if you wish to remain anonymous please use a different name or enter 'Anon' as the name.
We regret that we are unable to privately answer questions left as comments. So please do not include your phone number, email or mailing address in the body of your comment. For the best personal and direct response to your colorectal cancer treatment questions, please call our Answer Line at 1-877-4CRC-111 (1-877-427-2111).