For more information regarding these studies, contact Cancer Research at (601) 984-1095
CACTUX: Phase 2 Single Arm Trial of Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients with Incurable Head and Neck Squamous Cell Carcinoma (HNSCC)
This study is being done for head and neck cancer that cannot be cured.
The purpose of this research study is to look at the effect of a treatment regimen called CACTUX on head and neck cancer. The CACTUX regimen is a combination of three drugs called cisplatin, nab-paclitaxel, and cetuximab (carboplatin may be substituted if previous problems receiving cisplatin). The use of nab-paclitaxel in this combination is different from routine care, in which a drug called 5FU is often given instead. We are looking at the side effects with the CACTUX regimen as well as the response of the cancer and the patient's overall health.
Cetuximab has been approved by the FDA for the treatment of head and neck cancer. Cisplatin, carboplatin, and nab-paclitaxel have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of other kinds of cancer, but they are considered experimental for the treatment of head and neck cancer, which means that they have not been approved by the FDA for this use. The combination of cisplatin (or carboplatin), nab-paclitaxel, and cetuximab is also considered experimental.
Principal Investigator: R. Darryl Hamilton, MD
RTOG 1216: Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck
This study has two study parts, Phase II and Phase III. Phase III will not begin until Phase II is complete. You will only participate in one part of the study, not both. Phase II: The purpose of the Phase II study is to find out what effects, good and/or bad, the following treatments have on you and your cancer:
Phase III: The purpose of the Phase III study is to compare the effects, good and/or bad, of the standard treatment (radiation therapy and cisplatin) to one of the experimental treatments (either radiation therapy and docetaxel or radiation therapy, cetuximab, and docetaxel) chosen from the Phase II study. The experimental treatment offered in the Phase III study will be based on information collected in the Phase II study. Cisplatin and docetaxel are standard chemotherapy drugs used to treat head and neck cancers, but in this study docetaxel is given in a different dose and schedule than it normally is given and is considered experimental. Cetuximab is a drug that blocks the epidermal growth factor receptor, which is a protein that aids growth and other functions of cancer cells.
Principal Investigator: Madhava Rao Kanakamedala, MD